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FDA ANDA · ANDA077723

HYDROCODONE BITARTRATE AND IBUPROFEN

Sponsor: STRIDES PHARMA

APPLICATION
ANDA077723
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-06
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 10MG, IBUPROFEN 200MG · TABLET · ORAL
HYDROCODONEDiscontinued
HYDROCODONE BITARTRATE 5MG, IBUPROFEN 200MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 38AP
2025-12-22Labeling · Supplement 37 · standardAP
2024-11-21Labeling · Supplement 36 · standardAP
2024-10-31REMS · Supplement 35AP
2024-10-03Labeling · Supplement 34 · standardAP
2023-12-15Labeling · Supplement 33 · standardAP
2023-12-15Labeling · Supplement 32 · standardAP
2021-09-02Labeling · Supplement 31 · standardAP
2021-04-30Labeling · Supplement 30 · standardAP
2021-03-04Labeling · Supplement 29 · standardAP
2019-10-11Labeling · Supplement 27 · standardAP
2019-07-22Labeling · Supplement 26 · standardAP
2018-09-21Labeling · Supplement 23 · standardAP
2018-09-18REMS · Supplement 21 · standardAP
2018-09-14Labeling · Supplement 19 · standardAP
2015-04-03Labeling · Supplement 4AP
2015-04-03Labeling · Supplement 16 · standardAP
2013-04-23Labeling · Supplement 9AP
2007-12-31Labeling · Supplement 1AP
2007-04-03Labeling · Supplement 2AP
2006-11-06Original — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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