APPLICATION
ANDA200343
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG/15ML, HYDROCODONE BITARTRATE 7.5MG/15ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 26AP
2025-12-22Labeling · Supplement 25 · standardAP
2024-10-31REMS · Supplement 24AP
2024-03-11Labeling · Supplement 23 · standardAP
2023-12-15Labeling · Supplement 21 · standardAP
2021-03-04Labeling · Supplement 15 · standardAP
2019-10-11Labeling · Supplement 11 · standardAP
2018-09-21Labeling · Supplement 5 · standardAP
2018-09-18REMS · Supplement 4AP
2016-12-16Labeling · Supplement 2 · standardAP
2016-12-16Labeling · Supplement 3 · 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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