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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075982

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NDA 075982 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Merro Pharm Usa, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Nostrum Labs Inc, and Rising, and is included in forty-four NDAs. It is available from forty-two 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. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 075982

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Pliva
Ingredient:	tramadol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075982

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 1, 2002	TE:		RLD:	No

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