Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications, 65986 [2019-25946]
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65986
Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4590]
Morton Grove Pharmaceuticals, Inc., et
al.; Withdrawal of Approval of 21
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of 21 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
January 2, 2020.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21CFR
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.
Application No.
Drug
Applicant
ANDA 040759 ........
Phenytoin Sodium Capsules, 30milligrams (mg) (Extended)
ANDA 062349 ........
Nystatin Oral Suspension, 100,000 units/milliters (mL) ........
ANDA 062483 ........
Griseofulvin V (griseofulvin microsize) Oral Suspension,
125 mg/5 mL.
Amikacin Sulfate Injection USP, Equivalent to (EQ) 250 mg
base/mL.
Amantadine Hydrochloride (HCl) Syrup USP, 50 mg/5 mL ..
Cimetidine HCl Oral Solution, EQ 300 mg base/5 mL ..........
Sotalol HCl Tablets USP 80 mg, 120 mg, 160 mg, and 240
mg.
Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg
Fentanyl Extended-Release Film, 25 micrograms (mcg)/hr,
50 mcg/hr, 75 mcg/hr, 100 mcg/hr.
Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton
Grove, IL 60053.
G&W Laboratories, Inc., 301 Helen St., South Plainfield, NJ
07080.
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
G&W Laboratories, Inc.
Do.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple
Grove, MN 55369.
Do.
Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc, 577 Chipeta Way, Salt Lake City, UT
84108.
G&W Laboratories, Inc.
Mayne Pharma LLC, 1240 Sugg Parkway, Greenville, NC
27834.
Morton Grove Pharmaceuticals Inc.
Do.
Do.
ANDA 063264 ........
ANDA 072655 ........
ANDA 074176 ........
ANDA 075366 ........
ANDA 075887 ........
ANDA 076709 ........
ANDA 076841 ........
ANDA 077062 ........
ANDA 078426 ........
ANDA 078653 ........
ANDA 078701 ........
ANDA 078884 ........
ANDA 087811 ........
ANDA 088761 ........
ANDA 088762 ........
ANDA 090786 ........
ANDA 091267 ........
ANDA 201947 ........
Mesalamine Enema, 4 grams (gm)/60 mL ............................
Fentanyl Extended-Release Film, 25 mcg/hr, 50 mcg/hr, 75
mcg/hr, and 100 mcg/hr.
Zolpidem Tartrate Tablets, 5 mg and 10 mg .........................
Ranitidine HCl Tablets USP, EQ 150 mg base .....................
Ranitidine HCl Tablets USP, EQ 150 mg base and EQ 300
mg base.
Ranitidine HCl Tablets USP, EQ 75 mg base .......................
Phrenilin (acetaminophen and butalbital) Tablets, 325 mg/
50 mg.
Prometh VC Plain (promethazine HCl and phenylephrine
HCl) Syrup, 5 mg/5mL, and 6.25 mg/5 mL.
Prometh w/Dextromethorphan (promethazine HCl and
dextromethorphan hydrobromide) Syrup, 6.25 mg/5 mL
and 15 mg/5 mL.
Carbidopa, Entacapone, and Levodopa Tablets, 12.5 mg/
200 mg/50 mg.
Donepezil HCl Tablets, 5 mg and 10 mg ..............................
Morphine Sulfate Oral Solution, 10 mg/5 mL and 20 mg/5
mL.
Do.
Bausch Health US, LLC.
G&W Laboratories, Inc.
Do.
Morton Grove Pharmaceuticals Inc.
Do.
VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771.
jbell on DSKJLSW7X2PROD with NOTICES
Do = Ditto.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 2,
2020. Approval of each entire
application is withdrawn, including any
strengths or products inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
VerDate Sep<11>2014
17:10 Nov 29, 2019
Jkt 250001
products that are listed in the table that
are in inventory on January 2, 2020 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3995]
[FR Doc. 2019–25946 Filed 11–29–19; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Submission of
Information on Pediatric Uses of
Medical Devices
BILLING CODE 4164–01–P
AGENCY:
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
PO 00000
Food and Drug Administration,
HHS.
Frm 00022
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]]>Agencies
[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Page 65986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25946]
[[Page 65986]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4590]
Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of
Approval of 21 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 21 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of January 2, 2020.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected]. SUPPLEMENTARY INFORMATION: The
applicants listed in the table have informed FDA that these drug
products are no longer marketed and have requested that FDA withdraw
approval of the applications under the process described in Sec.
314.150(c) (21CFR 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040759.................. Phenytoin Sodium Morton Grove
Capsules, Pharmaceuticals,
30milligrams (mg) Inc., 6451 Main
(Extended). St., Morton Grove,
IL 60053.
ANDA 062349.................. Nystatin Oral G&W Laboratories,
Suspension, 100,000 Inc., 301 Helen
units/milliters St., South
(mL). Plainfield, NJ
07080.
ANDA 062483.................. Griseofulvin V Valeant
(griseofulvin Pharmaceuticals
microsize) Oral North America,
Suspension, 125 mg/ LLC, 400 Somerset
5 mL. Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 063264.................. Amikacin Sulfate Hospira, Inc., 275
Injection USP, North Field Dr.,
Equivalent to (EQ) Bldg. H1, Lake
250 mg base/mL. Forest, IL 60045.
ANDA 072655.................. Amantadine G&W Laboratories,
Hydrochloride (HCl) Inc.
Syrup USP, 50 mg/5
mL.
ANDA 074176.................. Cimetidine HCl Oral Do.
Solution, EQ 300 mg
base/5 mL.
ANDA 075366.................. Sotalol HCl Tablets Upsher-Smith
USP 80 mg, 120 mg, Laboratories, LLC,
160 mg, and 240 mg. 6701 Evenstad Dr.,
Maple Grove, MN
55369.
ANDA 075887.................. Fluvoxamine Maleate Do.
Tablets, 25 mg, 50
mg, and 100 mg.
ANDA 076709.................. Fentanyl Extended- Actavis
Release Film, 25 Laboratories UT,
micrograms (mcg)/ Inc., Subsidiary
hr, 50 mcg/hr, 75 of Teva
mcg/hr, 100 mcg/hr. Pharmaceuticals
USA, Inc, 577
Chipeta Way, Salt
Lake City, UT
84108.
ANDA 076841.................. Mesalamine Enema, 4 G&W Laboratories,
grams (gm)/60 mL. Inc.
ANDA 077062.................. Fentanyl Extended- Mayne Pharma LLC,
Release Film, 25 1240 Sugg Parkway,
mcg/hr, 50 mcg/hr, Greenville, NC
75 mcg/hr, and 100 27834.
mcg/hr.
ANDA 078426.................. Zolpidem Tartrate Morton Grove
Tablets, 5 mg and Pharmaceuticals
10 mg. Inc.
ANDA 078653.................. Ranitidine HCl Do.
Tablets USP, EQ 150
mg base.
ANDA 078701.................. Ranitidine HCl Do.
Tablets USP, EQ 150
mg base and EQ 300
mg base.
ANDA 078884.................. Ranitidine HCl Do.
Tablets USP, EQ 75
mg base.
ANDA 087811.................. Phrenilin Bausch Health US,
(acetaminophen and LLC.
butalbital)
Tablets, 325 mg/50
mg.
ANDA 088761.................. Prometh VC Plain G&W Laboratories,
(promethazine HCl Inc.
and phenylephrine
HCl) Syrup, 5 mg/
5mL, and 6.25 mg/5
mL.
ANDA 088762.................. Prometh w/ Do.
Dextromethorphan
(promethazine HCl
and
dextromethorphan
hydrobromide)
Syrup, 6.25 mg/5 mL
and 15 mg/5 mL.
ANDA 090786.................. Carbidopa, Morton Grove
Entacapone, and Pharmaceuticals
Levodopa Tablets, Inc.
12.5 mg/200 mg/50
mg.
ANDA 091267.................. Donepezil HCl Do.
Tablets, 5 mg and
10 mg.
ANDA 201947.................. Morphine Sulfate VistaPharm, Inc.,
Oral Solution, 10 7265 Ulmerton Rd.,
mg/5 mL and 20 mg/5 Largo, FL 33771.
mL.
------------------------------------------------------------------------
Do = Ditto.
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 2, 2020. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on January 2, 2020 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: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25946 Filed 11-29-19; 8:45 am]
BILLING CODE 4164-01-P
