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FDA ANDA · ANDA040355
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA040355
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 47AP
2025-12-22Labeling · Supplement 46 · standardAP
2025-12-22Labeling · Supplement 44 · standardAP
2024-10-31REMS · Supplement 45AP
2023-12-15Labeling · Supplement 43 · standardAP
2021-03-04Labeling · Supplement 42 · standardAP
2019-10-11Labeling · Supplement 41 · standardAP
2019-10-11Labeling · Supplement 39 · standardAP
2018-09-21Labeling · Supplement 36 · standardAP
2018-09-18REMS · Supplement 35 · standardAP
2016-12-16Labeling · Supplement 31 · standardAP
2016-12-16Labeling · Supplement 34 · standardAP
2016-12-16Labeling · Supplement 29 · standardAP
2016-12-15Labeling · Supplement 28 · standardAP
2016-12-15Labeling · Supplement 30 · standardAP
2016-12-15Labeling · Supplement 22 · standardAP
2013-10-22Labeling · Supplement 20 · standardAP
2011-07-01Labeling · Supplement 10AP
2003-07-08Labeling · Supplement 4AP
2002-11-18Labeling · Supplement 2AP
2002-06-06Manufacturing (CMC) · 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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