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FDA ANDA · ANDA087762

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: PURACAP PHARM

APPLICATION
ANDA087762
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-10
LATEST ACTION
1988-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1988-10-04Labeling · Supplement 11AP
1988-05-17Manufacturing (CMC) · Supplement 10AP
1988-05-17Manufacturing (CMC) · Supplement 9AP
1983-10-12Manufacturing (CMC) · Supplement 2AP
1983-10-12Manufacturing (CMC) · Supplement 3AP
1982-12-10OriginalAP
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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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