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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Baxter
Accenture
Healthtrust
QuintilesIMS
Chinese Patent Office
Mallinckrodt
AstraZeneca
McKinsey

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081235

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NDA 081235 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 twenty-two 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-nine suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 081235
Tradename:METHOTREXATE SODIUM
Applicant:Mylan
Ingredient:methotrexate sodium
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 081235
Suppliers and Packaging for NDA: 081235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 081235 ANDA Mylan Pharmaceuticals Inc. 0378-0014 N 0378-0014-01
METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 081235 ANDA Mylan Institutional Inc. 51079-670 N 51079-670-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:May 15, 1992TE:ABRLD:No

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