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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Medtronic
Dow
Teva
Fuji
Cantor Fitzgerald
Covington
Baxter
Merck

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205702

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NDA 205702 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 205702
Tradename:TRAMADOL HYDROCHLORIDE
Applicant:Macleods Pharms Ltd
Ingredient:tramadol hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 205702
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 205702
Suppliers and Packaging for NDA: 205702
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 205702 ANDA Macleods Pharmaceuticals Limited 33342-201 N 33342-201-11
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 205702 ANDA Macleods Pharmaceuticals Limited 33342-201 N 33342-201-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 25, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Harvard Business School
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