APPLICATION
ANDA040881
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG/15ML, HYDROCODONE BITARTRATE 10MG/15ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 21AP
2025-12-22Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 18AP
2024-02-27Labeling · Supplement 17 · standardAP
2023-12-15Labeling · Supplement 16 · standardAP
2021-03-04Labeling · Supplement 13 · standardAP
2019-10-11Labeling · Supplement 12 · standardAP
2018-09-21Labeling · Supplement 11 · standardAP
2018-09-18REMS · Supplement 10AP
2018-08-24Labeling · Supplement 9 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 7 · standardAP
2016-12-15Labeling · Supplement 6 · standardAP
2016-12-15Labeling · Supplement 5 · standardAP
2013-10-18Labeling · Supplement 3 · standardAP
2011-06-24Labeling · 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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