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FDA ANDA · ANDA090118
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: SUN PHARM INDS INC
APPLICATION
ANDA090118
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-23
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 38AP
2025-12-22Labeling · Supplement 37 · standardAP
2025-12-22Labeling · Supplement 35 · standardAP
2024-10-31REMS · Supplement 36AP
2023-12-15Labeling · Supplement 34 · standardAP
2021-03-04Labeling · Supplement 33 · standardAP
2019-10-11Labeling · Supplement 32 · standardAP
2018-09-21Labeling · Supplement 29 · standardAP
2018-09-18REMS · Supplement 27AP
2016-12-16Labeling · Supplement 23 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 22 · standardAP
2016-12-15Labeling · Supplement 16 · standardAP
2016-12-15Labeling · Supplement 14 · standardAP
2013-10-25Labeling · Supplement 13 · standardAP
2011-06-27Labeling · Supplement 2AP
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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