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FDA ANDA · ANDA089512

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: ROXANE

APPLICATION
ANDA089512
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-25
LATEST ACTION
1997-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 500MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL

Approval history

1997-11-19Labeling · Supplement 2AP
1990-02-07Labeling · Supplement 1AP
1989-04-25OriginalAP
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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