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FDA ANDA · ANDA040236

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MUTUAL PHARM

APPLICATION
ANDA040236
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-25
LATEST ACTION
2002-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 750MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2002-07-24Manufacturing (CMC) · Supplement 8AP
2002-02-08Manufacturing (CMC) · Supplement 7AP
2001-11-02Manufacturing (CMC) · Supplement 5AP
2001-09-24Manufacturing (CMC) · Supplement 6AP
2000-12-18Manufacturing (CMC) · Supplement 4AP
2000-12-18Manufacturing (CMC) · Supplement 2AP
2000-12-18Manufacturing (CMC) · Supplement 3AP
2000-12-18Manufacturing (CMC) · Supplement 1AP
1997-09-25OriginalAP
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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