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Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089342

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NDA 089342 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 089342
Applicant:West-ward Pharms Int
Ingredient:methotrexate sodium
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089342
Suppliers and Packaging for NDA: 089342
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089342 ANDA West-Ward Pharmaceuticals Corp 0143-9517 N 0143-9517-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/8ML (EQ 25MG BASE/ML)
Approval Date:Sep 16, 1986TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Chinese Patent Office
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Daiichi Sankyo

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