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FDA ANDA · ANDA089363

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: MIKART

APPLICATION
ANDA089363
TYPE
ANDA
ORIGINAL APPROVAL
1991-09-25
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 650MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL

Approval history

2002-08-13Manufacturing (CMC) · Supplement 5AP
1998-07-31Manufacturing (CMC) · Supplement 4AP
1995-08-21Manufacturing (CMC) · Supplement 3AP
1994-08-04Labeling · Supplement 1AP
1991-09-25OriginalAP
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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