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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091498

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NDA 091498 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 091498

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Cspc Ouyi Pharm Co
Ingredient:	tramadol hydrochloride
Patents:	0
Therapeutic Class:	Analgesics
Formulation / Manufacturing:	see details

Pharmacology for NDA: 091498

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 091498

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 091498

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	091498	ANDA	Medsource Pharmaceuticals	45865-357	N	45865-357-20
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	091498	ANDA	Medsource Pharmaceuticals	45865-357	N	45865-357-60

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 29, 2013	TE:	AB	RLD:	No

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