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FDA ANDA · ANDA211023
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: WES PHARMA INC
APPLICATION
ANDA211023
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-08
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 7AP
2025-12-22Labeling · Supplement 6 · standardAP
2024-10-31REMS · Supplement 5AP
2024-02-27Labeling · Supplement 4 · standardAP
2023-12-15Labeling · Supplement 3 · standardAP
2022-11-15Labeling · 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.
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