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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 201973

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NDA 201973 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-three 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 201973

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Ipca Labs Ltd
Ingredient:	tramadol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 201973

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 16, 2012	TE:	AB	RLD:	No

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