APPLICATION
ANDA040248
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-28
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
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
Approval history
2025-12-22Labeling · Supplement 12 · standardAP
2025-10-24Labeling · Supplement 11 · standardAP
2024-01-02Labeling · Supplement 9 · standardAP
2024-01-02Labeling · Supplement 10 · standardAP
2021-03-04Labeling · Supplement 8 · standardAP
2019-10-11Labeling · Supplement 7 · standardAP
2018-09-21Labeling · Supplement 6 · standardAP
2018-09-18REMS · Supplement 5AP
2016-12-16Labeling · Supplement 3 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2015-11-02Labeling · 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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