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Details for New Drug Application (NDA): 011719

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NDA 011719 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, Sandoz Inc, West-ward Pharms Int, and Pharmachemie Bv, and is included in fourteen NDAs. It is available from seven 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-three suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for NDA: 011719

Tradename:
METHOTREXATE LPF
Applicant:
Hospira
Ingredient:
methotrexate sodium
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 011719

Suppliers and Packaging for NDA: 011719

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE LPF
methotrexate sodium
INJECTABLE;INJECTION 011719 NDA Hospira Worldwide, Inc. 61703-350 61703-350-38 5 VIAL in 1 CARTON (61703-350-38) > 2 mL in 1 VIAL (61703-350-37)
METHOTREXATE PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION 011719 NDA Hospira Worldwide, Inc. 61703-350 61703-350-38 5 VIAL in 1 CARTON (61703-350-38) > 2 mL in 1 VIAL (61703-350-37)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2.5MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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