Last Updated: May 10, 2026

Details for New Drug Application (NDA): 075964

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NDA 075964 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, 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 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 sixty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 075964

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Sun Pharm Inds Inc
Ingredient:	tramadol hydrochloride
Patents:	0

Pharmacology for NDA: 075964

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 075964

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 075964

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075964	ANDA	RedPharm Drug, Inc.	67296-1021	67296-1021-1	10 TABLET in 1 BOTTLE (67296-1021-1)
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075964	ANDA	RedPharm Drug, Inc.	67296-1021	67296-1021-2	20 TABLET in 1 BOTTLE (67296-1021-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 19, 2002	TE:	AB	RLD:	No

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