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Generated: November 18, 2018

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Details for New Drug Application (NDA): 040265

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NDA 040265 describes METHOTREXATE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa and Hospira and is included in three NDAs. It is available from two suppliers. Additional details are available on the METHOTREXATE PRESERVATIVE FREE profile page.

The generic ingredient in METHOTREXATE 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 040265
Applicant:Fresenius Kabi Usa
Ingredient:methotrexate sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 040265
Suppliers and Packaging for NDA: 040265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040265 ANDA Fresenius Kabi USA, LLC 63323-121 63323-121-02 1 VIAL in 1 CARTON (63323-121-02) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/ML
Approval Date:Feb 26, 1999TE:APRLD:No

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