APPLICATION
ANDA077454
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-23
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 5MG, IBUPROFEN 200MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 13AP
2025-12-22Labeling · Supplement 12 · standardAP
2024-11-21Labeling · Supplement 11 · standardAP
2024-10-31REMS · Supplement 10AP
2024-10-02Labeling · Supplement 9 · standardAP
2023-12-15Labeling · Supplement 8 · standardAP
2021-04-28Labeling · Supplement 7 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2019-10-11Labeling · Supplement 5 · standardAP
2019-07-22Labeling · Supplement 4 · standardAP
2018-09-21Labeling · Supplement 2 · standardAP
2018-09-18REMS · Supplement 3AP
2018-08-15Labeling · Supplement 1 · standardAP
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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