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FDA ANDA · ANDA076914
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: GRAVITI PHARMS
APPLICATION
ANDA076914
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-26
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, TRAMADOL HYDROCHLORIDE 37.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 11AP
2025-12-29Labeling · Supplement 10 · standardAP
2024-10-31REMS · Supplement 9AP
2023-12-19Labeling · Supplement 8 · standardAP
2023-12-18Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 6AP
2017-06-16Labeling · 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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