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FDA ANDA · ANDA089080

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: PUREPAC PHARM

APPLICATION
ANDA089080
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-17
LATEST ACTION
1991-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL

Approval history

1991-04-16Labeling · Supplement 8AP
1990-12-12Labeling · Supplement 7AP
1989-06-29Labeling · Supplement 4AP
1989-06-29Labeling · Supplement 3AP
1986-07-17OriginalAP
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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