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FDA ANDA · ANDA040736
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: AMNEAL PHARMS NY
APPLICATION
ANDA040736
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 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 39AP
2025-12-22Labeling · Supplement 38 · standardAP
2025-11-25Labeling · Supplement 36 · standardAP
2024-10-31REMS · Supplement 37AP
2023-12-15Labeling · Supplement 35 · standardAP
2023-12-15Labeling · Supplement 34 · standardAP
2023-12-13Labeling · Supplement 29 · standardAP
2023-12-13Labeling · Supplement 31 · standardAP
2021-03-04Labeling · Supplement 28 · standardAP
2019-10-10Labeling · Supplement 21 · standardAP
2018-09-21Labeling · Supplement 19 · standardAP
2018-09-18REMS · Supplement 18AP
2016-12-16Labeling · Supplement 17 · standardAP
2016-12-16Labeling · Supplement 16 · standardAP
2016-01-05Labeling · Supplement 14 · standardAP
2014-04-04Labeling · Supplement 12 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 8AP
2011-06-24Labeling · Supplement 10AP
2008-03-20Manufacturing (CMC) · Supplement 1AP
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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