Document ID: FDA-2020-N-2197-0002
Agency: fda
Document Type: Notice
Title: VistaPharm, Inc., et.al.; Withdrawal of Approval of 10 Abbreviated New Drug 
Applications; Correction
Posted Date: 2021-03-12T05:00Z

[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14130-14131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05103]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2197]

VistaPharm, Inc., et.al.; Withdrawal of Approval of 10 
Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on December 11, 2020. The 
document announced the withdrawal of approval (as of January 11, 2021) 
of 10 abbreviated new drug applications (ANDAs) from multiple 
applicants. The document indicated that FDA was withdrawing approval of 
the following two ANDAs after receiving a withdrawal request from 
VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771: ANDA 040323, 
Prednisolone Syrup, 15 milligrams (mg)/5 milliliters (mL); and ANDA 
075782, Valproic Acid Syrup, 250 mg/5 mL. Before FDA withdrew the 
approval of these ANDAs, VistaPharm, Inc., informed FDA that it did not 
want

[[Page 14131]]

the approval of the ANDAs withdrawn. Because VistaPharm, Inc., timely 
requested that approval of these ANDAs not be withdrawn, the approval 
of ANDAs 040323 and 075782 are still in effect.

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: In the Federal Register of Friday, December 
11, 2020 (85 FR 80119), appearing in FR Doc. 2020-27303, the following 
correction is made:
    On page 80119, in the table, the entries for ANDAs 040323 and 
075782 are removed.

    Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05103 Filed 3-11-21; 8:45 am]
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