[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70835-70836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25315]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2826]
Allergan Sales, LLC, et al.; Withdrawal of Approval of 10
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 10 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of December 21, 2022.
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) (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.
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Application No. Drug Applicant
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ANDA 040099................. Norco (hydrocodone bitartrate and Allergan Sales, LLC, U.S. Agent for
acetaminophen) Tablets, 5 milligrams Allergan Pharmaceuticals International
(mg)/325 mg. Limited, 5 Giralda Farms, Madison, NJ
07940.
ANDA 040148................. Norco (hydrocodone bitartrate and Do.
acetaminophen) Tablets, 2.5 mg/325 mg,
5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325
mg, and 10 mg/500 mg.
ANDA 076434................. Chlorhexidine Gluconate Solution, 0.12%. Sunstar Americas, Inc., 301 East Central
Rd., Schaumburg, IL 60195.
ANDA 079076................. Ranitidine Hydrochloride (HCl) Mylan Pharmaceuticals Inc., a Viatris
Injection, Equivalent to (EQ) 25 mg Company, U.S. Agent for Mylan
base/milliliters (mL). Laboratories Limited, 3711 Collins
Ferry Rd., Morgantown, WV 26505.
ANDA 090054................. Ranitidine HCl Syrup, EQ 15 mg base/mL.. Tolmar Inc., 701 Centre Ave., Fort
Collins, CO 80526.
ANDA 201804................. Letrozole Tablets, 2.5 mg............... Indicus Pharma, LLC, 2530 Meridian
Parkway, Durham, NC 27713.
ANDA 201832................. Nimodipine Capsules, 30 mg.............. Sofgen Pharmaceuticals, LLC, 21500
Biscayne Blvd., Suite 600, Aventura, FL
33180.
ANDA 203419................. Donepezil HCl Tablets, 23 mg............ Indicus Pharma, LLC.
ANDA 203519................. Morphine Sulfate Solution, 20 mg/5 mL... Tris Pharma, Inc., 2033 Route 130, Suite
D, Monmouth Junction, NJ 08852.
ANDA 206151................. Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma USA, Inc., U.S. Agent
EQ 600 mg base; 300 mg. for Aurobindo Pharma Limited, 279
Princeton-Hightstown Rd., East Windsor,
NJ 08520.
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[[Page 70836]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 21, 2022. Approval of each entire application is withdrawn,
including any strengths and dosage forms 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 December 21, 2022 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 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25315 Filed 11-18-22; 8:45 am]
BILLING CODE 4164-01-P