APPLICATION
ANDA077858
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-26
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, TRAMADOL HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 20AP
2025-12-23Labeling · Supplement 19 · standardAP
2025-12-15Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 18AP
2023-12-15Labeling · Supplement 16 · standardAP
2023-12-01Labeling · Supplement 14 · standardAP
2023-12-01Labeling · Supplement 12 · standardAP
2023-12-01Labeling · Supplement 10 · standardAP
2018-09-18REMS · Supplement 7AP
2018-02-26Labeling · Supplement 6 · standardAP
2015-07-02Labeling · Supplement 5 · standardAP
2015-07-02Labeling · Supplement 4 · 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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