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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090039

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NDA 090039 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 seven 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 090039
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:Sandoz Inc
Ingredient:methotrexate sodium
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090039
Suppliers and Packaging for NDA: 090039
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 090039 ANDA Sandoz Inc 66758-040 N 66758-040-02
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 090039 ANDA Sandoz Inc 66758-040 N 66758-040-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:Mar 31, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date:Mar 31, 2009TE:APRLD:No

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