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Generated: September 19, 2018

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Details for New Drug Application (NDA): 040843

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NDA 040843 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 040843
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:Pharmachemie Bv
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040843
Suppliers and Packaging for NDA: 040843
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040843 ANDA Teva Parenteral Medicines, Inc. 0703-3671 0703-3671-03 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-03) > 2 mL in 1 VIAL, SINGLE-DOSE (0703-3671-01)
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040843 ANDA Teva Parenteral Medicines, Inc. 0703-3671 0703-3671-93 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-93) > 2 mL in 1 VIAL, SINGLE-DOSE (0703-3671-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date:Jan 11, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:Jan 11, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date:Feb 27, 2012TE:APRLD:No

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