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FDA ANDA · ANDA081095

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Sponsor: MIKART

APPLICATION
ANDA081095
TYPE
ANDA
ORIGINAL APPROVAL
1990-10-26
LATEST ACTION
1998-07-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 150MG, ASPIRIN 180MG, CODEINE PHOSPHATE 15MG · CAPSULE · ORAL

Approval history

1998-07-31Manufacturing (CMC) · Supplement 4AP
1991-12-09Labeling · Supplement 2AP
1991-12-09Manufacturing (CMC) · Supplement 3AP
1991-12-09Manufacturing (CMC) · Supplement 1AP
1990-10-26OriginalAP
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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