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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
US Army

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089340

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NDA 089340 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, Pharmachemie Bv, Sandoz Inc, and West-ward Pharms Int, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the METHOTREXATE SODIUM PRESERVATIVE FREE profile page.

The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE 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 089340
Applicant:West-ward Pharms Int
Ingredient:methotrexate sodium
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089340
Suppliers and Packaging for NDA: 089340
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 089340 ANDA West-Ward Pharmaceuticals Corp 0143-9519 N 0143-9519-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:Sep 16, 1986TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Army
Fish and Richardson

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