APPLICATION
ANDA040432
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-22
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2025-12-22Labeling · Supplement 18 · standardAP
2025-10-24Labeling · Supplement 17 · standardAP
2023-12-15Labeling · Supplement 15 · standardAP
2023-12-15Labeling · Supplement 16 · standardAP
2021-03-05Labeling · Supplement 14 · standardAP
2019-10-28Labeling · Supplement 13 · standardAP
2018-09-21Labeling · Supplement 12 · standardAP
2018-09-18REMS · Supplement 11AP
2018-08-15Labeling · Supplement 10 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2016-02-23Labeling · Supplement 7 · standardAP
2011-06-27Labeling · Supplement 5AP
2003-10-10Labeling · 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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