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FDA ANDA · ANDA085363

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: KV PHARM

APPLICATION
ANDA085363
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-23
LATEST ACTION
1998-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

1998-06-26Manufacturing (CMC) · Supplement 20AP
1991-09-12Manufacturing (CMC) · Supplement 17AP
1991-03-22Labeling · Supplement 18AP
1989-03-10Labeling · Supplement 16AP
1988-05-04Labeling · Supplement 15AP
1984-01-24Manufacturing (CMC) · Supplement 9AP
1983-12-07Manufacturing (CMC) · Supplement 8AP
1983-10-07Manufacturing (CMC) · Supplement 7AP
1977-08-23OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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