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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040266

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NDA 040266 describes METHOTREXATE PRESERVATIVE FREE, which is a drug marketed by Hospira and Fresenius Kabi Usa 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-six suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for NDA: 040266

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040266

Suppliers and Packaging for NDA: 040266

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION 040266 ANDA Fresenius Kabi USA, LLC 63323-122 63323-122-59 1 VIAL in 1 CARTON (63323-122-59) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
METHOTREXATE PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION 040266 ANDA Fresenius Kabi USA, LLC 63323-122 63323-122-50 1 VIAL in 1 CARTON (63323-122-50) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Feb 26, 1999TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Army
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Fish and Richardson
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