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Generated: November 18, 2018

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Details for New Drug Application (NDA): 011719

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NDA 011719 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 011719
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:Hospira
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 011719
Suppliers and Packaging for NDA: 011719
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE LPF methotrexate sodium INJECTABLE;INJECTION 011719 NDA Hospira, Inc. 61703-350 61703-350-38 5 VIAL in 1 CARTON (61703-350-38) > 2 mL in 1 VIAL (61703-350-37)
METHOTREXATE PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 011719 NDA Hospira, Inc. 61703-350 61703-350-38 5 VIAL in 1 CARTON (61703-350-38) > 2 mL in 1 VIAL (61703-350-37)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2.5MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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