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Details for New Drug Application (NDA): 200171

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NDA 200171 describes METHOTREXATE PRESERVATIVE FREE, which is a drug marketed by Hospira, Fresenius Kabi Usa, and Pharmachemie Bv, and is included in four 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-three suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for NDA: 200171

Tradename:
METHOTREXATE PRESERVATIVE FREE
Applicant:
Pharmachemie Bv
Ingredient:
methotrexate sodium
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date:Feb 27, 2012TE:APRLD: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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