APPLICATION
ANDA040482
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-25
LATEST ACTION
2025-12-22
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
2025-12-22Labeling · Supplement 25 · standardAP
2024-02-27Labeling · Supplement 24 · standardAP
2023-12-15Labeling · Supplement 23 · standardAP
2021-03-05Labeling · Supplement 22 · standardAP
2019-10-28Labeling · Supplement 21 · standardAP
2018-09-21Labeling · Supplement 20 · standardAP
2018-09-18REMS · Supplement 19AP
2018-08-15Labeling · Supplement 18 · standardAP
2016-12-16Labeling · Supplement 16 · standardAP
2016-12-16Labeling · Supplement 17 · standardAP
2016-12-15Labeling · Supplement 15 · standardAP
2013-10-18Labeling · Supplement 13 · standardAP
2011-06-24Labeling · Supplement 10AP
2009-03-30Labeling · Supplement 8AP
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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