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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075963

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NDA 075963 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Par Pharm Inc, Sun Pharm, 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 Pharms Inc, Northstar Hlthcare, Pliva, Polygen Pharms, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem Labs Ltd, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Graviti Pharms, Micro Labs Ltd India, Nostrum Labs Inc, and Par Pharm, and is included in forty-four NDAs. It is available from thirty-eight 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 075963
Tradename:TRAMADOL HYDROCHLORIDE
Applicant:Ivax Sub Teva Pharms
Ingredient:tramadol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075963

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Jul 3, 2002TE:RLD:No

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