APPLICATION
ANDA090415
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-24
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 30AP
2025-02-11Labeling · Supplement 26 · standardAP
2024-10-31REMS · Supplement 28AP
2023-12-18Labeling · Supplement 25 · standardAP
2023-12-18Labeling · Supplement 24 · standardAP
2021-03-04Labeling · Supplement 23 · standardAP
2019-10-11Labeling · Supplement 18 · standardAP
2019-10-11Labeling · Supplement 20 · standardAP
2018-09-21Labeling · Supplement 17 · standardAP
2018-09-18REMS · Supplement 16 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2016-12-15Labeling · Supplement 4 · standardAP
2016-12-15Labeling · Supplement 7 · standardAP
2014-04-23Labeling · Supplement 2 · standardAP
2011-06-24Labeling · Supplement 1AP
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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