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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075964

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NDA 075964 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan Pharms Inc, Par Pharm Inc, Sun Pharma Global, Accord Hlthcare, Aci Healthcare Ltd, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Fosun Pharma, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan, Northstar Hlthcare, Pliva, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Apotex Inc, Micro Labs Ltd India, and Par Pharm, and is included in forty-one NDAs. It is available from fifty-seven 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. Thirty-six 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
Therapeutic Class:	Analgesics
Formulation / Manufacturing:	see details

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	Northstar Rx LLC	16714-481	N	16714-481-01
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075964	ANDA	Northstar Rx LLC	16714-481	N	16714-481-02

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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