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FDA ANDA · ANDA040285

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA040285
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-19
LATEST ACTION
2002-02-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEDiscontinued
HOMATROPINE METHYLBROMIDE 1.5MG/5ML, HYDROCODONE BITARTRATE 5MG/5ML · SYRUP · ORAL

Approval history

2002-02-08Manufacturing (CMC) · Supplement 6AP
2001-11-02Manufacturing (CMC) · Supplement 5AP
2000-12-18Manufacturing (CMC) · Supplement 3AP
2000-12-18Manufacturing (CMC) · Supplement 1AP
2000-12-18Manufacturing (CMC) · Supplement 4AP
2000-12-18Manufacturing (CMC) · Supplement 2AP
1999-07-19Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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