← FDA DRUG APPROVALS

FDA NDA · NDA005213

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Sponsor: GENUS

APPLICATION
NDA005213
TYPE
NDA
ORIGINAL APPROVAL
1943-03-23
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SYRUP, TABLET
MARKETING STATUS
Prescription

Products

HYCODAN · ReferencePrescription
HOMATROPINE METHYLBROMIDE 1.5MG/5ML, HYDROCODONE BITARTRATE 5MG/5ML · SYRUP · ORAL
HYCODAN · ReferencePrescription
HOMATROPINE METHYLBROMIDE 1.5MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2025-12-22Labeling · Supplement 48 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 46 · standard — Label ↗AP
2021-09-27Manufacturing (CMC) · Supplement 44 · standard — Label ↗AP
2018-06-28Labeling · Supplement 39 · standard — Label ↗AP
2017-01-13Labeling · Supplement 38 · standard — Label ↗AP
2009-01-26Labeling · Supplement 37 · standard — Letter ↗AP
2002-01-16Manufacturing (CMC) · Supplement 30 · standardAP
2001-06-15Manufacturing (CMC) · Supplement 29 · standardAP
2000-07-10Manufacturing (CMC) · Supplement 27 · standardAP
1999-04-23Manufacturing (CMC) · Supplement 28 · standardAP
1992-04-22Manufacturing (CMC) · Supplement 24 · standardAP
1988-12-23Manufacturing (CMC) · Supplement 22 · standardAP
1988-11-08Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP
1988-07-26Labeling · Supplement 15AP
1988-07-26Efficacy · Supplement 13AP
1988-07-26Manufacturing (CMC) · Supplement 14 · standardAP
1943-03-23Type 1 - New Molecular Entity · Original · standardAP
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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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