← FDA DRUG APPROVALS
FDA ANDA · ANDA040838
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: PHARM ASSOC
APPLICATION
ANDA040838
TYPE
ANDA
ORIGINAL APPROVAL
2013-05-10
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG/15ML, HYDROCODONE BITARTRATE 7.5MG/15ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 27AP
2025-12-22Labeling · Supplement 24 · standardAP
2024-10-31REMS · Supplement 23AP
2024-02-27Labeling · Supplement 22 · standardAP
2023-12-15Labeling · Supplement 20 · standardAP
2021-03-04Labeling · Supplement 17 · standardAP
2019-10-11Labeling · Supplement 15 · standardAP
2018-09-21Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 11AP
2016-12-16Labeling · Supplement 5 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2016-12-15Labeling · Supplement 2 · standardAP
2013-10-18Labeling · Supplement 1 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.