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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201530

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NDA 201530 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 201530

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201530

Suppliers and Packaging for NDA: 201530

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201530 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0149 0069-0149-01 40 mL in 1 VIAL (0069-0149-01)
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201530 ANDA Mylan Institutional LLC 67457-480 67457-480-40 1 VIAL in 1 CARTON (67457-480-40) > 40 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date:Mar 29, 2012TE:APRLD:No


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