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FDA ANDA · ANDA061529

PENICILLIN V POTASSIUM

Sponsor: BELCHER PHARMS

APPLICATION
ANDA061529
TYPE
ANDA
ORIGINAL APPROVAL
1971-11-17
LATEST ACTION
1997-07-09
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

PENICILLIN V POTASSIUMDiscontinued
PENICILLIN V POTASSIUM EQ 125MG BASE/5ML · FOR SOLUTION · ORAL
PENICILLIN V POTASSIUMDiscontinued
PENICILLIN V POTASSIUM EQ 250MG BASE/5ML · FOR SOLUTION · ORAL

Approval history

1997-07-09Labeling · Supplement 21AP
1986-08-08Manufacturing (CMC) · Supplement 20AP
1986-06-24Manufacturing (CMC) · Supplement 19AP
1971-11-17OriginalAP
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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