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FDA ANDA · ANDA040405
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: SPECGX LLC
APPLICATION
ANDA040405
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-08
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ANEXSIA 7.5/325Prescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 43AP
2025-02-11Labeling · Supplement 40 · standardAP
2024-10-31REMS · Supplement 41AP
2023-12-15Labeling · Supplement 38 · standardAP
2023-12-15Labeling · Supplement 39 · standardAP
2021-03-04Labeling · Supplement 34 · standardAP
2019-10-11Labeling · Supplement 30 · standardAP
2018-09-20Labeling · Supplement 28 · standardAP
2018-09-18REMS · Supplement 27AP
2016-12-16Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 23 · standardAP
2013-10-25Labeling · Supplement 20 · standardAP
2011-06-24Labeling · Supplement 17AP
2010-09-15Labeling · Supplement 16AP
2006-03-27Labeling · Supplement 13AP
2003-10-10Labeling · Supplement 7AP
2002-11-13Labeling · Supplement 6AP
2002-08-26Labeling · Supplement 5AP
2002-08-08Manufacturing (CMC) · Supplement 4AP
2001-11-30Labeling · Supplement 3AP
2001-01-26Manufacturing (CMC) · Supplement 1AP
2001-01-26Labeling · Supplement 2AP
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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