Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205702

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NDA 205702 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms, 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, Rising, and Zydus Pharms Usa Inc, and is included in forty-six NDAs. It is available from thirty-eight suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 205702

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

Medical Subject Heading (MeSH) Categories for 205702

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 25, 2015	TE:		RLD:	No

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