APPLICATION
ANDA040894
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-19
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG/15ML, HYDROCODONE BITARTRATE 7.5MG/15ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 28AP
2025-12-22Labeling · Supplement 27 · standardAP
2024-10-31REMS · Supplement 25AP
2024-03-11Labeling · Supplement 24 · standardAP
2023-12-15Labeling · Supplement 22 · standardAP
2022-04-20Manufacturing (CMC) · Supplement 21 · standardAP
2021-03-04Labeling · Supplement 16 · standardAP
2019-10-07Labeling · Supplement 12 · standardAP
2018-09-21Labeling · Supplement 11 · standardAP
2018-09-18REMS · Supplement 10 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2016-12-16Labeling · Supplement 5 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-01-05Labeling · Supplement 2 · standardAP
2013-10-18Labeling · 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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