Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203407

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NDA 203407 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, and West-ward Pharms Int, and is included in thirteen NDAs. It is available from six 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-four suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 203407
Tradename:METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:Sagent Pharms Inc
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:Aug 9, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date:Aug 9, 2018TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date:Aug 9, 2018TE:APRLD:No

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