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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090404

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NDA 090404 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ph Health, Strides Pharma Intl, Sun Pharm, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Puracap Labs Blu, Rubicon Research, Senores Pharms, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Mpp Pharma, Rising, and Zydus Pharms Usa Inc, and is included in forty-five NDAs. It is available from forty-one suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE 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 090404

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Senores Pharms
Ingredient:	tramadol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090404

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jan 31, 2011	TE:	AB	RLD:	No

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