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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 040632


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NDA 040632 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Hikma, Hospira, Pharmachemie Bv, Rising, Sagent Pharms Inc, and Sandoz, and is included in thirteen NDAs. It is available from four 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-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 040632
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:Hikma
Ingredient:methotrexate sodium
Patents:0
Pharmacology for NDA: 040632
Suppliers and Packaging for NDA: 040632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040632 ANDA Hikma Pharmaceuticals USA Inc. 0143-9367 0143-9367-01 1 VIAL in 1 BOX (0143-9367-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040632 ANDA Hikma Pharmaceuticals USA Inc. 0143-9830 0143-9830-01 1 VIAL in 1 BOX (0143-9830-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 12, 2005TE:RLD:No

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