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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Farmers Insurance
QuintilesIMS
Medtronic
Cantor Fitzgerald
Express Scripts
Federal Trade Commission
Argus Health

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201749

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NDA 201749 describes METHOTREXATE SODIUM, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hospira, Norbrook, Pharmachemie Usa, West-ward Pharms Int, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Mylan, Sun Pharma Global, Zydus Pharms Usa Inc, Accord Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, and Sandoz Inc, and is included in thirty-one NDAs. It is available from seventeen suppliers. Additional details are available on the METHOTREXATE SODIUM profile page.

The generic ingredient in METHOTREXATE SODIUM is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 201749
Tradename:METHOTREXATE SODIUM
Applicant:Sun Pharma Global
Ingredient:methotrexate sodium
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201749
Suppliers and Packaging for NDA: 201749
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 201749 ANDA Sun Pharma Global FZE 47335-235 N 47335-235-96
METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 201749 ANDA Sun Pharma Global FZE 47335-235 N 47335-235-83

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:May 21, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Express Scripts
Daiichi Sankyo
Healthtrust
Fish and Richardson
QuintilesIMS
Federal Trade Commission
Deloitte

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