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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Mallinckrodt
US Department of Justice
Fuji
Merck
Fish and Richardson
Moodys
Teva
Accenture

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076003

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NDA 076003 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 076003
Tradename:TRAMADOL HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:tramadol hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076003
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076003
Suppliers and Packaging for NDA: 076003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 076003 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8005 N 0615-8005-39
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 076003 ANDA Blenheim Pharmacal, Inc. 10544-009 E 10544-009-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 20, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Teva
McKinsey
Julphar
US Department of Justice
Daiichi Sankyo
Boehringer Ingelheim
Harvard Business School
Dow

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