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FDA ANDA · ANDA087423

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: SANDOZ

APPLICATION
ANDA087423
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-22
LATEST ACTION
1988-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL

Approval history

1988-10-14Labeling · Supplement 17AP
1988-06-03Labeling · Supplement 11AP
1985-09-19Manufacturing (CMC) · Supplement 9AP
1985-09-19Manufacturing (CMC) · Supplement 7AP
1983-05-18Manufacturing (CMC) · Supplement 1AP
1983-05-18Manufacturing (CMC) · Supplement 2AP
1982-12-08Manufacturing (CMC) · Supplement 4AP
1981-07-22OriginalAP
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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