BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Farmers Insurance
US Army
Queensland Health
Chinese Patent Office

Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040263

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NDA 040263 describes METHOTREXATE SODIUM, which is a drug marketed by Zydus Pharms Usa Inc, Hospira, Abraxis Pharm, Duramed Pharms Barr, Mylan, West-ward Pharms Int, Norbrook, Orion Corp Orion, Pharmachemie Usa, Fresenius Kabi Usa, Dava Pharms Inc, Barr, Accord Hlthcare, Mylan Labs Ltd, Sandoz Inc, and Pharmachemie Bv, and is included in thirty NDAs. It is available from twenty suppliers. Additional details are available on the METHOTREXATE SODIUM profile page.

The generic ingredient in METHOTREXATE SODIUM 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 040263

Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040263

Suppliers and Packaging for NDA: 040263

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methotrexate sodium
INJECTABLE;INJECTION 040263 ANDA Fresenius Kabi USA, LLC 63323-123 63323-123-10 1 VIAL in 1 CARTON (63323-123-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:Feb 26, 1999TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date:Feb 26, 1999TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Johnson and Johnson
Boehringer Ingelheim

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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