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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075964

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NDA 075964 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, Anchen Pharms, Cspc Ouyi Pharm Co, Micro Labs Ltd India, Par Pharm, Apogee Pharma, and Apotex Inc, 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-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 075964

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075964

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 075964

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tramadol hydrochloride
TABLET;ORAL 075964 ANDA STAT Rx USA LLC 16590-229 16590-229-10 10 TABLET in 1 BOTTLE (16590-229-10)
tramadol hydrochloride
TABLET;ORAL 075964 ANDA STAT Rx USA LLC 16590-229 16590-229-15 15 TABLET in 1 BOTTLE (16590-229-15)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Johnson and Johnson
Express Scripts
Farmers Insurance
Harvard Business School
Fish and Richardson

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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