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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
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QuintilesIMS
Chubb
Colorcon
Citi
Cerilliant
McKinsey

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201384

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NDA 201384 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, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mallinckrodt, Mylan, Northstar Hlthcare, Pliva, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Watson Labs, Zydus Pharms Usa Inc, Apogee Pharma, 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-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 201384

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 201384

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 201384

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 201384 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-790 35356-790-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-790-30)
TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 201384 ANDA Sun Pharma Global FZE 47335-859 47335-859-18 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Dec 7, 2011TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Dec 7, 2011TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Dec 7, 2011TE:AB1RLD:No


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Serving leading biopharmaceutical companies globally:

Express Scripts
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Healthtrust

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