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FDA ANDA · ANDA040746

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: AMNEAL PHARMS NY

APPLICATION
ANDA040746
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 39AP
2025-12-22Labeling · Supplement 38 · standardAP
2024-10-31REMS · Supplement 37AP
2024-02-06Labeling · Supplement 36 · standardAP
2024-02-05Labeling · Supplement 35 · standardAP
2024-02-05Labeling · Supplement 34 · standardAP
2024-02-01Labeling · Supplement 31 · standardAP
2021-03-04Labeling · Supplement 29 · standardAP
2019-10-10Labeling · Supplement 23 · standardAP
2018-09-21Labeling · Supplement 21 · standardAP
2018-09-18REMS · Supplement 20AP
2016-12-16Labeling · Supplement 17 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2016-05-10Manufacturing (CMC) · Supplement 12AP
2015-07-02Labeling · Supplement 15 · standardAP
2014-06-23Labeling · Supplement 13 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 8AP
2011-06-24Labeling · Supplement 10AP
2008-03-20Manufacturing (CMC) · Supplement 1AP
2006-08-25Original — REMS ↗AP
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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