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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075977

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NDA 075977 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 forty-five 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 suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 075977
Tradename:TRAMADOL HYDROCHLORIDE
Applicant:Teva
Ingredient:tramadol hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075977
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 075977
Suppliers and Packaging for NDA: 075977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075977 ANDA Teva Pharmaceuticals USA, Inc. 0093-0058 N 0093-0058-01
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075977 ANDA Teva Pharmaceuticals USA, Inc. 0093-0058 N 0093-0058-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 19, 2002TE:ABRLD:No

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