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FDA ANDA · ANDA062273

BEEPEN-VK

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APPLICATION
ANDA062273
TYPE
ANDA
ORIGINAL APPROVAL
1980-08-12
LATEST ACTION
1998-04-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BEEPEN-VKDiscontinued
PENICILLIN V POTASSIUM EQ 250MG BASE · TABLET · ORAL
BEEPEN-VKDiscontinued
PENICILLIN V POTASSIUM EQ 500MG BASE · TABLET · ORAL

Approval history

1998-04-20Manufacturing (CMC) · Supplement 6AP
1996-03-06Labeling · Supplement 5AP
1989-02-06Manufacturing (CMC) · Supplement 4AP
1980-08-12OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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