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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 078783

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NDA 078783 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 078783

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Strides Pharma Intl
Ingredient:	tramadol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078783

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 13, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Nov 13, 2009	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Sep 20, 2011	TE:		RLD:	No

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