Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications; Correction, 131 [2017-28253]
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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices
131
TABLE 1—Continued
Application
No.
Drug
Applicant
ANDA 086742
Isosorbide Dinitrate Tablets USP, 5 mg .....................................
Gerimal (ergoloid mesylates) Sublingual Tablets, 1 mg ............
Nandrolone Decanoate Injection, 50 mg/mL ..............................
Wigraine (ergotamine tartrate and caffeine) Tablets USP, 1
mg/100 mg.
Choledyl SA (oxtriphylline) Extended-Release Tablets, 600 mg
ANDA 086863
Chlorpromazine HCl Oral Concentrate USP, 100 mg/mL ..........
ANDA 087233
Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg .................
ANDA 087244
ANDA
087318..
ANDA 087727
Ergoloid Mesylates Tablets USP, 1 mg ......................................
Tolbutamide Tablets USP, 500 mg ............................................
Do.
Do.
Do.
Organon USA, Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
ANDA 088128
Nandrolone Decanoate Injection, 200 mg/mL ............................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
088337
088477
088561
088564
088724
088734
088769
Ergostat (ergotamine tartrate) Sublingual Tablets USP, 2 mg ...
Thioridazine HCl Tablets USP, 15 mg .......................................
Thioridazine HCl Tablets USP, 10 mg .......................................
Thioridazine HCl Tablets USP, 100 mg .....................................
Methyclothiazide Tablets USP, 5 mg .........................................
Meclizine HCl Tablets, 25 mg .....................................................
Mepivacaine HCl Injection USP, 1% ..........................................
ANDA
ANDA
ANDA
ANDA
ANDA
088770
088872
089026
089027
089530
Mepivacaine HCl Injection USP, 2% ..........................................
Thioridazine HCl Tablets USP, 200 mg .....................................
Procainamide HCl Extended-Release Tablets USP, 250 mg ....
Procainamide HCl Extended-Release Tablets USP, 500 mg ....
Prochlorperazine Edisylate Injection USP, EQ 5 mg base/mL ..
ANDA
ANDA
ANDA
ANDA
086034
086188
086385
086562
Aminophylline Oral Solution USP, 105 mg/5 mL (Dye Free) .....
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of February 1,
2018. 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 table 1
that are in inventory on the date that
this notice becomes effective (see DATES)
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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–28254 Filed 12–29–17; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:54 Dec 29, 2017
Jkt 244001
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5715]
Watson Laboratories, Inc., and Barr
Laboratories, Inc., Subsidiaries of Teva
Pharmaceuticals USA, Inc.; Withdrawal
of Approval of 54 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 24, 2017. The
document announced the withdrawal of
approval of 54 abbreviated new drug
applications (ANDAs) from two
applicants, effective November 24, 2017.
The notice inadvertently announced the
withdrawal of approval for ANDA
087296 for Chlorthalidone Tablets USP,
25 milligrams, held by Watson
Laboratories, Inc., a subsidiary of Teva
Pharmaceuticals USA, Inc., 425 Privet
Rd., Horsham, PA 19044. FDA confirms
that the approval of ANDA 087296 is
still in effect.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945.
SUPPLEMENTARY INFORMATION: In FR Doc.
2017–23046, appearing on page 49214
in the Federal Register of Tuesday,
October 24, 2017, the following
correction is made:
1. On page 49215, in table 1, the entry
for ANDA 087296 is removed.
Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–28253 Filed 12–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–1846]
Labeling for Combined Hormonal
Contraceptives; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\02JAN1.SGM
02JAN1
]]>Agencies
[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Page 131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28253]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5715]
Watson Laboratories, Inc., and Barr Laboratories, Inc.,
Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval
of 54 Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of October 24, 2017. The document
announced the withdrawal of approval of 54 abbreviated new drug
applications (ANDAs) from two applicants, effective November 24, 2017.
The notice inadvertently announced the withdrawal of approval for ANDA
087296 for Chlorthalidone Tablets USP, 25 milligrams, held by Watson
Laboratories, Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., 425
Privet Rd., Horsham, PA 19044. FDA confirms that the approval of ANDA
087296 is still in effect.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.
SUPPLEMENTARY INFORMATION: In FR Doc. 2017-23046, appearing on page
49214 in the Federal Register of Tuesday, October 24, 2017, the
following correction is made:
1. On page 49215, in table 1, the entry for ANDA 087296 is removed.
Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28253 Filed 12-29-17; 8:45 am]
BILLING CODE 4164-01-P
