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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Farmers Insurance

Generated: September 22, 2017

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 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, Atlas Pharms Llc, and Apotex Inc, and is included in forty-one NDAs. It is available from fifty-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. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for NDA: 205702

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 205702

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 205702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tramadol hydrochloride
TABLET;ORAL 205702 ANDA Macleods Pharmaceuticals Limited 33342-201 33342-201-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-201-11)
tramadol hydrochloride
TABLET;ORAL 205702 ANDA Macleods Pharmaceuticals Limited 33342-201 33342-201-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-201-15)

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Queensland Health
Fish and Richardson
Express Scripts

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