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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 077858

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NDA 077858 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, Mpp Pharma, Rising, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from thirteen suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 077858

Tradename:	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Applicant:	Rising
Ingredient:	acetaminophen; tramadol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;37.5MG
Approval Date:	Sep 26, 2008	TE:	AB	RLD:	No

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