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FDA ANDA · ANDA086681

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: PUREPAC PHARM

APPLICATION
ANDA086681
TYPE
ANDA
ORIGINAL APPROVAL
1979-05-11
LATEST ACTION
2001-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2001-11-02Manufacturing (CMC) · Supplement 32AP
2001-04-18Manufacturing (CMC) · Supplement 31AP
1998-04-07Manufacturing (CMC) · Supplement 30AP
1996-01-18Manufacturing (CMC) · Supplement 29AP
1994-09-29Labeling · Supplement 28AP
1993-09-08Manufacturing (CMC) · Supplement 26AP
1991-07-03Manufacturing (CMC) · Supplement 22AP
1991-07-03Manufacturing (CMC) · Supplement 21AP
1991-02-26Labeling · Supplement 25AP
1990-11-15Labeling · Supplement 24AP
1989-06-29Labeling · Supplement 23AP
1989-01-10Manufacturing (CMC) · Supplement 20AP
1987-04-22Manufacturing (CMC) · Supplement 19AP
1985-11-14Manufacturing (CMC) · Supplement 16AP
1985-03-12Manufacturing (CMC) · Supplement 15AP
1984-10-18Manufacturing (CMC) · Supplement 13AP
1984-10-18Manufacturing (CMC) · Supplement 11AP
1984-10-18Manufacturing (CMC) · Supplement 14AP
1984-10-18Manufacturing (CMC) · Supplement 12AP
1982-12-06Manufacturing (CMC) · Supplement 8AP
1979-05-11Original — Review ↗AP
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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