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Details for New Drug Application (NDA): 075981

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NDA 075981 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds, Macleods Pharms Ltd, Lupin Ltd, Amneal Pharms, Zydus Pharms Usa Inc, Sun Pharma Global, Actavis Elizabeth, Aurobindo Pharma Ltd, Northstar Hlthcare, Mylan Pharms Inc, Watson Labs, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Sandoz, Ipca Labs Ltd, Asta, Aci Healthcare Ltd, Teva, Apotex, Pliva, Par Pharm Inc, Mallinckrodt, Mylan, Accord Hlthcare Inc, Anchen Pharms, Cspc Ouyi Pharm Co, Micro Labs Ltd India, Par Pharm, Atlas Pharms Llc, and Apotex Inc, and is included in thirty-nine NDAs. It is available from sixty suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-five drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for NDA: 075981

Tradename:
TRAMADOL HYDROCHLORIDE
Applicant:
Apotex
Ingredient:
tramadol hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075981

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 075981

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL 075981 ANDA Apotex Corp. 60505-0171 60505-0171-1 100 TABLET, COATED in 1 BOTTLE (60505-0171-1)
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL 075981 ANDA Apotex Corp. 60505-0171 60505-0171-2 500 TABLET, COATED in 1 BOTTLE (60505-0171-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 10, 2002TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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