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FDA ANDA · ANDA091633
HYDROCODONE BITARTRATE AND IBUPROFEN
Sponsor: SUN PHARM INDS INC
APPLICATION
ANDA091633
TYPE
ANDA
ORIGINAL APPROVAL
2013-05-28
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
HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 5MG, IBUPROFEN 200MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 2.5MG, IBUPROFEN 200MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 19AP
2025-12-22Labeling · Supplement 18 · standardAP
2024-11-21Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 16AP
2024-10-09Labeling · Supplement 15 · standardAP
2023-12-15Labeling · Supplement 14 · standardAP
2021-05-04Labeling · Supplement 13 · standardAP
2021-03-04Labeling · Supplement 12 · standardAP
2019-10-11Labeling · Supplement 11 · standardAP
2019-07-22Labeling · Supplement 10 · standardAP
2018-09-20Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 7AP
2018-09-14Labeling · Supplement 8 · standardAP
2018-09-14Labeling · Supplement 3 · 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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