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FDA ANDA · ANDA076604
HYDROCODONE BITARTRATE AND IBUPROFEN
Sponsor: ACTAVIS LABS FL INC
APPLICATION
ANDA076604
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND IBUPROFENPrescription
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 32AP
2025-12-22Labeling · Supplement 31 · standardAP
2024-11-21Labeling · Supplement 30 · standardAP
2024-10-31REMS · Supplement 29AP
2024-10-03Labeling · Supplement 28 · standardAP
2023-12-15Labeling · Supplement 26 · standardAP
2023-12-15Labeling · Supplement 27 · standardAP
2021-04-28Labeling · Supplement 25 · standardAP
2021-03-04Labeling · Supplement 24 · standardAP
2019-10-11Labeling · Supplement 23 · standardAP
2019-08-23Labeling · Supplement 22 · standardAP
2018-09-21Labeling · Supplement 21 · standardAP
2018-09-18REMS · Supplement 20AP
2017-03-22Labeling · Supplement 18 · standardAP
2017-03-22Labeling · Supplement 19 · standardAP
2010-07-31Labeling · Supplement 15AP
2007-08-22Labeling · Supplement 4AP
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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