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Generated: April 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008085

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NDA 008085 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, Hq Spclt Pharma, Pharmachemie Usa, Fresenius Kabi Usa, Dava Pharms Inc, Barr, Accord Hlthcare, Mylan Labs Ltd, Sandoz Inc, and Pharmachemie Bv, and is included in thirty-two NDAs. It is available from nineteen 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-five suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for NDA: 008085

Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 008085

Suppliers and Packaging for NDA: 008085

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methotrexate sodium
TABLET;ORAL 008085 NDA Major Pharmaceuticals 0904-6012 0904-6012-60 100 TABLET in 1 BOTTLE (0904-6012-60)
methotrexate sodium
TABLET;ORAL 008085 NDA Rebel Distributors Corp 42254-110 42254-110-30 30 TABLET in 1 BOTTLE (42254-110-30)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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