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Generated: November 13, 2018

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Details for New Drug Application (NDA): 089343

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NDA 089343 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 089343
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:West-ward Pharms Int
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089343
Suppliers and Packaging for NDA: 089343
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 089343 ANDA West-Ward Pharmaceuticals Corp 0143-9516 0143-9516-01 1 VIAL in 1 BOX (0143-9516-01) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date:Sep 16, 1986TE:APRLD:No

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