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FDA ANDA · ANDA061528

PENICILLIN V POTASSIUM

Sponsor: BELCHER PHARMS

APPLICATION
ANDA061528
TYPE
ANDA
ORIGINAL APPROVAL
1971-11-18
LATEST ACTION
1997-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PENICILLIN V POTASSIUMDiscontinued
PENICILLIN V POTASSIUM EQ 250MG BASE · TABLET · ORAL
PENICILLIN V POTASSIUMDiscontinued
PENICILLIN V POTASSIUM EQ 500MG BASE · TABLET · ORAL

Approval history

1997-07-09Labeling · Supplement 1AP
1971-11-18OriginalAP
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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