Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six Abbreviated New Drug Applications, 35170-35172 [2014-14288]
Download as PDF
<![CDATA[
35170
Federal Register / Vol. 79, No. 118 / Thursday, June 19, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0662]
Aurobindo Pharma Ltd. et al.;
Withdrawal of Approval of Eighty-Six
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
SUMMARY:
approval of 86 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
DATES:
Effective Date: July 21, 2014.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in
table 1 in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
TABLE 1
Application No.
Drug
Applicant
ANDA 065395 .............................
Cefazolin for Injection USP, 500 milligrams (mg) and
1 gram (g).
Ceftazidime for Injection USP, 500 mg, 1 g, and 2 g
Ceftazidime for Injection USP, 6 g ..............................
Ceftriaxone for Injection USP, 10 g ............................
Ceftriaxime for Injection, 250 mg, 500 mg, 1 g, and 2
g.
Cefotaxime for Injection USP, 10 g .............................
Cefotaxime for Injection USP ......................................
Nateglinide Tablets, 60 mg and 120 mg .....................
Aurobindo Pharma Ltd., c/o AuroMedics Pharma
LLC, 6 Wheeling Rd. Dayton, NJ 08810.
Do.
Do.
Do.
Do.
ANDA
ANDA
ANDA
ANDA
065481
065482
065504
065505
.............................
.............................
.............................
.............................
ANDA 065516 .............................
ANDA 065517 .............................
ANDA 077467 .............................
ANDA 077472 .............................
ANDA 077540 .............................
ANDA 077717 .............................
ANDA 077730 .............................
ANDA 077826 .............................
ANDA 077888 .............................
Ondansetron Orally Disintegrating Tablets USP, 4 mg
and 8 mg.
Pravastatin Sodium Tablets, 10 mg, 20 mg, 30 mg,
40 mg, and 80 mg.
Fenoldopam Mesylate Injection USP, 10 mg (base)/
mL.
Ciprofloxacin Injection USP, 2 mg/mL ........................
ANDA 078016 .............................
Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200
mg.
Zolpidem Tartrate Tablets, 5 mg and 10 mg ..............
ANDA 078053 .............................
ANDA 078114 .............................
Sertraline HCl Oral Concentrate, 20 mg/mL ...............
Ciprofloxacin Injection USP in 5% Dextrose, 2 mg/mL
ANDA 078132 .............................
Ibuprofen Tablets USP, 400 mg, 600 mg, and 800
mg.
ANDA 078187 .............................
ANDA 078322 .............................
ANDA 078448 .............................
Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2
mg, 3 mg, and 4 mg.
Anastrozole Tablets, 1 mg ..........................................
Ranitidine HCl Solution, 15 mg/mL .............................
ANDA 078606 .............................
emcdonald on DSK67QTVN1PROD with NOTICES
ANDA 077905 .............................
Cetirizine Hydrochloride (HCl) Syrup, 5 mg/5 milliliters (mL).
Zolpidem Tartrate Tablets, 5 mg and 10 mg ..............
Mitoxantrone Injection USP .........................................
ANDA 080043 .............................
Nitrofurantoin Tablets, 50 mg and 100 mg .................
ANDA 080203 .............................
Potassium Chloride Injection USP, 2 milliequivalents/
mL.
Hydrocortisone Tablets, 20 mg ...................................
Aminophylline Injection USP, 25 mg/mL .....................
Glycopyrrolate Injection USP, 0.2 mg/mL ...................
Methyprednisolone Sodium Succinate for Injection
USP, 125 mg.
ANDA
ANDA
ANDA
ANDA
080642
081142
081169
081266
VerDate Mar<15>2010
.............................
.............................
.............................
.............................
17:25 Jun 18, 2014
Jkt 232001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Do.
Do.
Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O.
Box 1090, North Wales, PA 19454.
Ranbaxy Laboratories Limited, c/o Ranbaxy Inc., 600
College Rd. East, Princeton, NJ 08540.
Synthon Pharmaceuticals, Inc., 9000 Development
Dr., P.O. Box 110487, Research Triangle Park, NC
27709.
Nesher Pharmaceuticals (USA) LLC, 13910 St.
Charles Rock Rd., Bridgeton, MO 63044.
Pliva HRVATSKA, c/o Barr Laboratories, Inc., 400
Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
Teva Parenteral Medicines, Inc., 19 Hughes, Irvine,
CA 92618.
Baxter Healthcare Corp., 1620 Waukegan Rd.,
McGaw Park, IL 60085.
Pliva HRVATSKA, c/o Barr Laboratories, Inc.
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge
Rd., P.O. Box 4310, Morgantown, WV 26505–
4310.
Ranbaxy Laboratories Limited, c/o Ranbaxy Inc.
Bedford Laboratories, 300 Northfield Rd., Bedford,
OH 44146.
Quality Regulatory Consultants, U.S. Agent for
Northstar Healthcare Holdings, 501 Ivy Lake Dr.,
Forest, VA 24551.
Synthon Pharmaceuticals, Inc.
Do.
Ranbaxy Inc., U.S. Agaent for Ranbaxy Laboratories
Limited.
Washington Food and Drug Consultants, U.S. Agent
for Fresenius Kabi Oncology Plc., 3631 Martins
Dairy Circle, Olney, MD 20832.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO
80038–0446.
Baxter Healthcare Corp., 25212 W. IL Route 120,
Round Lake, IL 70073.
Sandoz Inc.
Teva Parenteral Medicines, Inc.
Do.
Do.
E:\FR\FM\19JNN1.SGM
19JNN1
Federal Register / Vol. 79, No. 118 / Thursday, June 19, 2014 / Notices
35171
TABLE 1—Continued
Application No.
Drug
ANDA 081267 .............................
Methylprednisolone Sodium Succinate for Injection
USP, 500 mg.
Methyprednisolone Sodium Succinate for Injection
USP, 1 g.
Leucovorin Calcium for Injection, 50 mg/vial ..............
Halothane USP ............................................................
ANDA 081268 .............................
ANDA 081278 .............................
ANDA 083254 .............................
ANDA
ANDA
ANDA
ANDA
083263
083306
083486
084051
.............................
.............................
.............................
.............................
ANDA 088099 .............................
ANDA 088175 .............................
Alcohol in Dextrose Injection USP, 5%/5% .................
Niacin Tablets, 50 mg .................................................
Isoproterenol HCl Injection USP, 0.2 mg/mL ..............
Dextroamphetamine Sulfate Tablets USP, 5 mg and
10 mg.
Promethazine HCl Tablets, 12.5 mg ...........................
Folic Acid Capsules, 1 mg ..........................................
Hydrochlorothiazide and Reserpine Tablets, 25 mg/
0.125 mg.
Phendimetrazine Tartrate Tablets, 35 mg ...................
Imipramine HCl Tablets, 50 mg ..................................
Imipramine HCl Tablets, 10 mg ..................................
Hydrochlorothiazide and Reserpine Tablets, 50 mg/
0.125 mg.
Estrogens, Esterified Tablets, 1.25 mg .......................
Novocaine (procaine HCl Injection USP) ....................
Dextroamphetamine Sulfate Tablets, 5 mg .................
Dextroamphetamine Sulfate Tablets, 10 mg ...............
Phendimetrazine Tartrate Tablets, 35 mg ...................
Triamcinolone Tablets, 4 mg .......................................
Phendimetrazine Tartrate Capsules, 35 mg ...............
Phentermine HCl Tablets, 8 mg ..................................
Phentermine HCl Tablets USP, 8 mg .........................
Phendimetrazine Tartrate Capsules, 35 mg ...............
Phendimetrazine Tartrate Capsules, 35 mg ...............
Phendimetrazine Tartrate Tablets, 35 mg ...................
A-Methapred (methylprednisolone sodium succinate
for injection USP), 1,000 mg/vial.
A-Methapred (methylprednisolone sodium succinate
for injection USP), 40 mg/vial.
A-Methapred (methylprednisolone sodium succinate
for injection USP), 500 mg/vial.
A-Hydrocort (hydrocortisone sodium succinate for injection USP), 100 mg/vial.
A-Hydrocort (hydrocortisone sodium succinate for injection USP), 250 mg/vial.
A-Hydrocort (hydrocortisone sodium succinate for injection USP), 500 mg/vial.
A-Hydrocort (hydrocortisone sodium for injection
USP), 1,000 mg/val.
Phendimetrazine Tartrate Tablets, 35 mg ...................
Barbidonna Tablets (phenobarbital, hyoscyamine sulfate, scopolamine hydrobromide, and atropine sulfate).
Barbidonna Elixir (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide).
Butibel Elixir (sodium butabarbital and belladonna extract), 15 mg/5 mL and 15 mg/5 mL.
Phentermine HCl Capsules, 30 mg .............................
Phentermine HCl Capsules, 30 mg .............................
Prochlorperazine Edisylate Injection USP ...................
Barbidonna
No.
2
Tablets
(phenobarbital,
hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide) 32 mg, 0.1286 mg, 0.025
mg, and 0.0074 mg.
Heparin Lock Flush Solution USP, 2,500 units/Ml ......
Chlorpropamide Tablets, 100 mg ................................
ANDA 088176 .............................
ANDA 088184 .............................
Chlorpropamide Tablets, 250 mg ................................
Hydroxyzine HCl Injection USP, 25 mg/mL ................
ANDA 088185 .............................
ANDA 088330 .............................
ANDA 089158 .............................
Hydroxyzine HCl Injection USP, 50 mg/mL ................
1.5% Lidocain HCl Injection USP ................................
Methotrexate Injection USP, 25 mg/mL ......................
ANDA 084233 .............................
ANDA 084472 .............................
ANDA 084827 .............................
ANDA
ANDA
ANDA
ANDA
085034
085133
085200
085213
.............................
.............................
.............................
.............................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
085302
085362
085370
085371
085402
085601
085633
085671
085689
085694
085702
085830
085852
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
ANDA 085853 .............................
ANDA 085854 .............................
ANDA 085929 .............................
ANDA 085930 .............................
ANDA 085931 .............................
ANDA 085932 .............................
ANDA 086370 .............................
ANDA 086589 .............................
ANDA 086590 .............................
ANDA 086664 .............................
ANDA
ANDA
ANDA
ANDA
emcdonald on DSK67QTVN1PROD with NOTICES
Applicant
087208
087223
087759
087572
VerDate Mar<15>2010
.............................
.............................
.............................
.............................
17:25 Jun 18, 2014
Jkt 232001
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Do.
Do.
Do.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL
60045.
Do.
Sandoz Inc.
Baxter Healthcare Corp.
Shire Development Inc., 725 Chesterbrook Blvd.,
Wayne, PA 19087.
Sandoz Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Sandoz Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Do.
Do.
Hospira, Inc.
Do.
Do.
Do.
Sandoz Inc.
Meda Pharmaceuticals, Meda Pharmaceuticals, Inc.,
265 Davidson Ave., Suite 300, Somerset, NJ
08873–4120.
Do.
Do.
Sandoz Inc.
Do.
Baxter Healthcare Corp.
Meda Pharmaceuticals.
Hospira, Inc.
Par Pharmaceutical, Inc., One Ram Ridge Rd.,
Spring Valley, NY 10977.
Do.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Do.
Hospira, Inc.
Pharmachemie B.V., c/o Teva Parenteral Medicines,
Inc., 19 Hughes, Irvine, CA 92618.
E:\FR\FM\19JNN1.SGM
19JNN1
35172
Federal Register / Vol. 79, No. 118 / Thursday, June 19, 2014 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 089420 .............................
ANDA 090183 .............................
ANDA 090196 .............................
ANDA 090464 .............................
Azdone Tablets (hydrocodone bitartrate 5 mg and aspirin 500 mg).
Cetirizine HCl Syrup, 5 mg/5mL ..................................
Letrozole Tablets USP, 2.5 mg ...................................
Mycophenolate Mofetil Tablets, 500 mg .....................
ANDA 090567 .............................
Polyethylene Glycol 3350 Powder for Oral Solution ...
ANDA 090712 .............................
Polyethylene Glycol 3350 and Electrolytes for Oral
Solution.
Clenz-Lyte (polyethylene glyol 3350 and electrolytes
for oral solution).
Mycophenolalte Mofetil Capsules USP, 250 mg .........
Schwarz Pharma, Inc., c/o UCB, Inc., 1950 Lake
Park Dr., Smyrna, GA 30080.
Ranbaxy Laboratories Limited, c/o Ranbaxy Inc.
Synthon Pharmaceuticals, Inc.
Dr. Reddy’s Laboratories Limited, c/o Dr. Reddy’s
Laboratories, Inc., 200 Somerset Corporate Blvd.,
7th Floor, Bridgewater, NJ 08807.
Paddock Laboratories, LLC, a Perrigo Co., 3940
Quebec Ave. North, Minneapolis, MN 55427.
Do.
ANDA 090769 .............................
ANDA 091315 .............................
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective July 21,
2014. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
table 1 that are in inventory on the date
that this notice becomes effective (see
the DATES section) may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
Dated: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14288 Filed 6–18–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0640]
emcdonald on DSK67QTVN1PROD with NOTICES
Draft Guidance for Industry on
Uncomplicated Gonorrhea: Developing
Drugs for Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Uncomplicated
SUMMARY:
VerDate Mar<15>2010
17:25 Jun 18, 2014
Jkt 232001
Do.
Dr. Reddy’s Laboratories Limited, c/o Dr. Reddy’s
Laboratories, Inc.
Gonorrhea: Developing Drugs for
Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the
development of new antibacterial drugs
for the treatment of uncomplicated
gonorrhea.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 17,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Uncomplicated Gonorrhea: Developing
Drugs for Treatment.’’ The purpose of
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
this draft guidance is to assist sponsors
in the development of new antibacterial
drugs for the treatment of
uncomplicated gonorrhea.
This draft guidance describes
approaches for trial designs for the
evaluation of new drugs for the
treatment of uncomplicated gonorrhea.
The draft guidance focuses on the
noninferiority trial design and describes
an efficacy endpoint for which there is
a well-defined treatment effect. The
draft guidance also provides the
justification for the noninferiority
margin. In addition, this guidance
reflects recent developments in
scientific information that pertain to
drugs being developed for the treatment
of uncomplicated gonorrhea.
Issuance of this draft guidance fulfills
a portion of the requirements of Title
VIII, section 804, of the Food and Drug
Administration Safety and Innovation
Act (Public Law 112–144) that requires
FDA to ‘‘. . . review and, as
appropriate, revise not fewer than 3
guidance documents per year . . . for
the conduct of clinical trials with
respect to antibacterial and antifungal
drugs. . . .’’ In 1998, FDA published a
draft guidance entitled ‘‘Uncomplicated
Gonorrhea: Developing Drugs for
Treatment’’ (1998 draft guidance). In a
Federal Register notice dated August 7,
2013 (78 FR 48175), FDA announced an
initiative in the Center for Drug
Evaluation and Research involving the
review of draft guidance documents
issued before 2010 to determine their
status and to decide whether those
guidances should be withdrawn,
revised, or finalized with only minor
changes. In the August 7, 2013, Federal
Register notice, FDA announced that
the 1998 draft guidance, as well as other
draft guidances, was being withdrawn
(78 FR 48175). FDA is now issuing a
new draft guidance that revises the
recommendations in the 1998 draft
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35170-35172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14288]
[[Page 35170]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0662]
Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-
Six Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 86 abbreviated new drug applications (ANDAs) from multiple
applicants. The holders of the applications notified the Agency in
writing that the drug products were no longer marketed and requested
that the approval of the applications be withdrawn.
DATES: Effective Date: July 21, 2014.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 065395................. Cefazolin for Aurobindo Pharma
Injection USP, 500 Ltd., c/o
milligrams (mg) and AuroMedics Pharma
1 gram (g). LLC, 6 Wheeling Rd.
Dayton, NJ 08810.
ANDA 065481................. Ceftazidime for Do.
Injection USP, 500
mg, 1 g, and 2 g.
ANDA 065482................. Ceftazidime for Do.
Injection USP, 6 g.
ANDA 065504................. Ceftriaxone for Do.
Injection USP, 10 g.
ANDA 065505................. Ceftriaxime for Do.
Injection, 250 mg,
500 mg, 1 g, and 2
g.
ANDA 065516................. Cefotaxime for Do.
Injection USP, 10 g.
ANDA 065517................. Cefotaxime for Do.
Injection USP.
ANDA 077467................. Nateglinide Tablets, Teva Pharmaceuticals
60 mg and 120 mg. USA, 1090 Horsham
Rd., P.O. Box 1090,
North Wales, PA
19454.
ANDA 077472................. Cetirizine Ranbaxy Laboratories
Hydrochloride (HCl) Limited, c/o
Syrup, 5 mg/5 Ranbaxy Inc., 600
milliliters (mL). College Rd. East,
Princeton, NJ
08540.
ANDA 077540................. Zolpidem Tartrate Synthon
Tablets, 5 mg and Pharmaceuticals,
10 mg. Inc., 9000
Development Dr.,
P.O. Box 110487,
Research Triangle
Park, NC 27709.
ANDA 077717................. Ondansetron Orally Nesher
Disintegrating Pharmaceuticals
Tablets USP, 4 mg (USA) LLC, 13910
and 8 mg. St. Charles Rock
Rd., Bridgeton, MO
63044.
ANDA 077730................. Pravastatin Sodium Pliva HRVATSKA, c/o
Tablets, 10 mg, 20 Barr Laboratories,
mg, 30 mg, 40 mg, Inc., 400 Chestnut
and 80 mg. Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 077826................. Fenoldopam Mesylate Teva Parenteral
Injection USP, 10 Medicines, Inc., 19
mg (base)/mL. Hughes, Irvine, CA
92618.
ANDA 077888................. Ciprofloxacin Baxter Healthcare
Injection USP, 2 mg/ Corp., 1620
mL. Waukegan Rd., McGaw
Park, IL 60085.
ANDA 077905................. Topiramate Tablets, Pliva HRVATSKA, c/o
25 mg, 50 mg, 100 Barr Laboratories,
mg, and 200 mg. Inc.
ANDA 078016................. Zolpidem Tartrate Mylan
Tablets, 5 mg and Pharmaceuticals,
10 mg. Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown,
WV 26505-4310.
ANDA 078053................. Sertraline HCl Oral Ranbaxy Laboratories
Concentrate, 20 mg/ Limited, c/o
mL. Ranbaxy Inc.
ANDA 078114................. Ciprofloxacin Bedford
Injection USP in 5% Laboratories, 300
Dextrose, 2 mg/mL. Northfield Rd.,
Bedford, OH 44146.
ANDA 078132................. Ibuprofen Tablets Quality Regulatory
USP, 400 mg, 600 Consultants, U.S.
mg, and 800 mg. Agent for Northstar
Healthcare
Holdings, 501 Ivy
Lake Dr., Forest,
VA 24551.
ANDA 078187................. Risperidone Tablets Synthon
USP, 0.25 mg, 0.5 Pharmaceuticals,
mg, 1 mg, 2 mg, 3 Inc.
mg, and 4 mg.
ANDA 078322................. Anastrozole Tablets, Do.
1 mg.
ANDA 078448................. Ranitidine HCl Ranbaxy Inc., U.S.
Solution, 15 mg/mL. Agaent for Ranbaxy
Laboratories
Limited.
ANDA 078606................. Mitoxantrone Washington Food and
Injection USP. Drug Consultants,
U.S. Agent for
Fresenius Kabi
Oncology Plc., 3631
Martins Dairy
Circle, Olney, MD
20832.
ANDA 080043................. Nitrofurantoin Sandoz Inc., 2555 W.
Tablets, 50 mg and Midway Blvd.,
100 mg. Broomfield, CO
80038-0446.
ANDA 080203................. Potassium Chloride Baxter Healthcare
Injection USP, 2 Corp., 25212 W. IL
milliequivalents/mL. Route 120, Round
Lake, IL 70073.
ANDA 080642................. Hydrocortisone Sandoz Inc.
Tablets, 20 mg.
ANDA 081142................. Aminophylline Teva Parenteral
Injection USP, 25 Medicines, Inc.
mg/mL.
ANDA 081169................. Glycopyrrolate Do.
Injection USP, 0.2
mg/mL.
ANDA 081266................. Methyprednisolone Do.
Sodium Succinate
for Injection USP,
125 mg.
[[Page 35171]]
ANDA 081267................. Methylprednisolone Do.
Sodium Succinate
for Injection USP,
500 mg.
ANDA 081268................. Methyprednisolone Do.
Sodium Succinate
for Injection USP,
1 g.
ANDA 081278................. Leucovorin Calcium Do.
for Injection, 50
mg/vial.
ANDA 083254................. Halothane USP....... Hospira, Inc., 275
North Field Dr.,
Lake Forest, IL
60045.
ANDA 083263................. Alcohol in Dextrose Do.
Injection USP, 5%/
5%.
ANDA 083306................. Niacin Tablets, 50 Sandoz Inc.
mg.
ANDA 083486................. Isoproterenol HCl Baxter Healthcare
Injection USP, 0.2 Corp.
mg/mL.
ANDA 084051................. Dextroamphetamine Shire Development
Sulfate Tablets Inc., 725
USP, 5 mg and 10 mg. Chesterbrook Blvd.,
Wayne, PA 19087.
ANDA 084233................. Promethazine HCl Sandoz Inc.
Tablets, 12.5 mg.
ANDA 084472................. Folic Acid Capsules, Do.
1 mg.
ANDA 084827................. Hydrochlorothiazide Do.
and Reserpine
Tablets, 25 mg/
0.125 mg.
ANDA 085034................. Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 085133................. Imipramine HCl Do.
Tablets, 50 mg.
ANDA 085200................. Imipramine HCl Do.
Tablets, 10 mg.
ANDA 085213................. Hydrochlorothiazide Do.
and Reserpine
Tablets, 50 mg/
0.125 mg.
ANDA 085302................. Estrogens, Do.
Esterified Tablets,
1.25 mg.
ANDA 085362................. Novocaine (procaine Hospira, Inc.
HCl Injection USP).
ANDA 085370................. Dextroamphetamine Sandoz Inc.
Sulfate Tablets, 5
mg.
ANDA 085371................. Dextroamphetamine Do.
Sulfate Tablets, 10
mg.
ANDA 085402................. Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 085601................. Triamcinolone Do.
Tablets, 4 mg.
ANDA 085633................. Phendimetrazine Do.
Tartrate Capsules,
35 mg.
ANDA 085671................. Phentermine HCl Do.
Tablets, 8 mg.
ANDA 085689................. Phentermine HCl Do.
Tablets USP, 8 mg.
ANDA 085694................. Phendimetrazine Do.
Tartrate Capsules,
35 mg.
ANDA 085702................. Phendimetrazine Do.
Tartrate Capsules,
35 mg.
ANDA 085830................. Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 085852................. A-Methapred Hospira, Inc.
(methylprednisolone
sodium succinate
for injection USP),
1,000 mg/vial.
ANDA 085853................. A-Methapred Do.
(methylprednisolone
sodium succinate
for injection USP),
40 mg/vial.
ANDA 085854................. A-Methapred Do.
(methylprednisolone
sodium succinate
for injection USP),
500 mg/vial.
ANDA 085929................. A-Hydrocort Hospira, Inc.
(hydrocortisone
sodium succinate
for injection USP),
100 mg/vial.
ANDA 085930................. A-Hydrocort Do.
(hydrocortisone
sodium succinate
for injection USP),
250 mg/vial.
ANDA 085931................. A-Hydrocort Do.
(hydrocortisone
sodium succinate
for injection USP),
500 mg/vial.
ANDA 085932................. A-Hydrocort Do.
(hydrocortisone
sodium for
injection USP),
1,000 mg/val.
ANDA 086370................. Phendimetrazine Sandoz Inc.
Tartrate Tablets,
35 mg.
ANDA 086589................. Barbidonna Tablets Meda
(phenobarbital, Pharmaceuticals,
hyoscyamine Meda
sulfate, Pharmaceuticals,
scopolamine Inc., 265 Davidson
hydrobromide, and Ave., Suite 300,
atropine sulfate). Somerset, NJ 08873-
4120.
ANDA 086590................. Barbidonna Elixir Do.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate,
scopolamine
hydrobromide).
ANDA 086664................. Butibel Elixir Do.
(sodium
butabarbital and
belladonna
extract), 15 mg/5
mL and 15 mg/5 mL.
ANDA 087208................. Phentermine HCl Sandoz Inc.
Capsules, 30 mg.
ANDA 087223................. Phentermine HCl Do.
Capsules, 30 mg.
ANDA 087759................. Prochlorperazine Baxter Healthcare
Edisylate Injection Corp.
USP.
ANDA 087572................. Barbidonna No. 2 Meda
Tablets Pharmaceuticals.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate, and
scopolamine
hydrobromide) 32
mg, 0.1286 mg,
0.025 mg, and
0.0074 mg.
ANDA 088099................. Heparin Lock Flush Hospira, Inc.
Solution USP, 2,500
units/Ml.
ANDA 088175................. Chlorpropamide Par Pharmaceutical,
Tablets, 100 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 088176................. Chlorpropamide Do.
Tablets, 250 mg.
ANDA 088184................. Hydroxyzine HCl Fresenius Kabi USA,
Injection USP, 25 LLC, Three
mg/mL. Corporate Dr., Lake
Zurich, IL 60047.
ANDA 088185................. Hydroxyzine HCl Do.
Injection USP, 50
mg/mL.
ANDA 088330................. 1.5% Lidocain HCl Hospira, Inc.
Injection USP.
ANDA 089158................. Methotrexate Pharmachemie B.V., c/
Injection USP, 25 o Teva Parenteral
mg/mL. Medicines, Inc., 19
Hughes, Irvine, CA
92618.
[[Page 35172]]
ANDA 089420................. Azdone Tablets Schwarz Pharma,
(hydrocodone Inc., c/o UCB,
bitartrate 5 mg and Inc., 1950 Lake
aspirin 500 mg). Park Dr., Smyrna,
GA 30080.
ANDA 090183................. Cetirizine HCl Ranbaxy Laboratories
Syrup, 5 mg/5mL. Limited, c/o
Ranbaxy Inc.
ANDA 090196................. Letrozole Tablets Synthon
USP, 2.5 mg. Pharmaceuticals,
Inc.
ANDA 090464................. Mycophenolate Dr. Reddy's
Mofetil Tablets, Laboratories
500 mg. Limited, c/o Dr.
Reddy's
Laboratories, Inc.,
200 Somerset
Corporate Blvd.,
7th Floor,
Bridgewater, NJ
08807.
ANDA 090567................. Polyethylene Glycol Paddock
3350 Powder for Laboratories, LLC,
Oral Solution. a Perrigo Co., 3940
Quebec Ave. North,
Minneapolis, MN
55427.
ANDA 090712................. Polyethylene Glycol Do.
3350 and
Electrolytes for
Oral Solution.
ANDA 090769................. Clenz-Lyte Do.
(polyethylene glyol
3350 and
electrolytes for
oral solution).
ANDA 091315................. Mycophenolalte Dr. Reddy's
Mofetil Capsules Laboratories
USP, 250 mg. Limited, c/o Dr.
Reddy's
Laboratories, Inc.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective July 21, 2014. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) may continue to be dispensed until the inventories
have been depleted or the drug products have reached their expiration
dates or otherwise become violative, whichever occurs first.
Dated: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14288 Filed 6-18-14; 8:45 am]
BILLING CODE 4164-01-P
