Document ID: FDA-2020-N-1866-0001
Agency: fda
Document Type: Notice
Title: Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New
Drug Applications
Posted Date: 2020-10-09T04:00Z

[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Page 64150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22403]

[[Page 64150]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1866]

Wockhardt Ltd., et al.; Withdrawal of Approval of Nine 
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 nine 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of November 9, 2020.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 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.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040533.................  Bethanechol Chloride  Morton Grove
                               Tablets, 10           Pharmaceuticals
                               milligrams (mg).      Inc./Wockhardt USA
                                                     LLC, 6451 Main St.,
                                                     Morton Grove, IL
                                                     60053.
ANDA 040534.................  Bethanechol Chloride  Do.
                               Tablets, 25 mg.
ANDA 075015.................  Acyclovir Sodium for  Fresenius Kabi USA,
                               Injection,            LLC, Three
                               Equivalent to (EQ)    Corporate Dr., Lake
                               500 mg base/vial.     Zurich, IL 60047.
ANDA 075773.................  Pamidronate Disodium  Do.
                               for Injection, 30
                               mg/vial, and 90 mg/
                               vial.
ANDA 076206.................  Calcitriol            Rockwell Medical,
                               Injection, 0.001 mg/  Inc., 30142 S.
                               milliliter (mL).      Wixom Rd., Wixom,
                                                     MI 48393.
ANDA 076207.................  Pamidronate Disodium  Fresenius Kabi USA,
                               Injection, 30 mg/10   LLC.
                               mL (3 mg/mL) and 90
                               mg/mL (9 mg/mL).
ANDA 077788.................  Albuterol Sulfate     VistaPharm, Inc.,
                               Syrup, EQ 2 mg base/  7265 Ulmerton Rd.,
                               5 mL.                 Largo, FL 33771.
ANDA 077990.................  Zolpidem Tartrate     Carlsbad Technology,
                               Tablets, 5 mg and     Inc., U.S. Agent
                               10 mg.                for Yung Shin
                                                     Pharmaceutical
                                                     Industrial Co.,
                                                     Ltd., 4761 Tara
                                                     Ct., West
                                                     Bloomfield, MI
                                                     48323.
ANDA 202410.................  Donepezil             Hisun Pharmaceutical
                               Hydrochloride         (Hangzhou) Co.,
                               Tablets, 23 mg.       Ltd., U.S. Agent,
                                                     Hisun
                                                     Pharmaceuticals
                                                     USA, Inc., 200
                                                     Crossing Blvd., 2nd
                                                     floor, Bridgewater,
                                                     NJ 08807.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
November 9, 2020. 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 November 9, 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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22403 Filed 10-8-20; 8:45 am]
BILLING CODE 4164-01-P