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Details for New Drug Application (NDA): 008085

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NDA 008085 describes METHOTREXATE SODIUM, which is a drug marketed by Hospira, Abraxis Pharm, Duramed Pharms Barr, Mylan, Eurohlth Intl Sarl, Norbrook, Hq Spclt Pharma, Roxane, Pharmachemie Usa, Fresenius Kabi Usa, Dava Pharms Inc, Barr, Accord Hlthcare, Mylan Labs Ltd, Sandoz Inc, West-ward Pharms Int, and Pharmachemie Bv, and is included in thirty-one NDAs. It is available from seventeen 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-three suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for NDA: 008085

Dava Pharms Inc
methotrexate sodium
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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