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Generated: November 15, 2018

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Details for New Drug Application (NDA): 040768

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NDA 040768 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms, Sandoz Inc, and West-ward Pharms Int, and is included in thirteen NDAs. It is available from six 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-seven suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 040768
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:Accord Hlthcare
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date:Apr 30, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Colorcon
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Citi
Teva
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Queensland Health
Johnson and Johnson

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