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FDA ANDA · ANDA088017

HYDROMET

hydrocodone bitartrate and homatropine methylbromide

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA088017
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-05
LATEST ACTION
2025-03-24
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

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

Approval history

2025-03-24Labeling · Supplement 55 · standardAP
2025-03-24Labeling · Supplement 53 · standardAP
2018-06-28Labeling · Supplement 49 · standardAP
2017-01-13Labeling · Supplement 48 · standardAP
2016-12-15Labeling · Supplement 47 · standardAP
2014-11-21Labeling · Supplement 45 · standardAP
2000-09-12Manufacturing (CMC) · Supplement 19AP
1997-09-22Manufacturing (CMC) · Supplement 17AP
1997-06-09Manufacturing (CMC) · Supplement 16AP
1992-11-02Manufacturing (CMC) · Supplement 14AP
1992-11-02Manufacturing (CMC) · Supplement 15AP
1992-06-19Manufacturing (CMC) · Supplement 13AP
1991-02-07Manufacturing (CMC) · Supplement 12AP
1990-09-28Manufacturing (CMC) · Supplement 11AP
1990-07-31Labeling · Supplement 9AP
1990-02-01Labeling · Supplement 10AP
1989-06-08Manufacturing (CMC) · Supplement 8AP
1988-03-11Labeling · Supplement 7AP
1987-02-13Manufacturing (CMC) · Supplement 5AP
1986-01-09Manufacturing (CMC) · Supplement 3AP
1986-01-09Manufacturing (CMC) · Supplement 4AP
1983-07-05OriginalAP
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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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