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Fuji
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AstraZeneca
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081235

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NDA 081235 describes METHOTREXATE SODIUM, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hospira, Norbrook, Pharmachemie Usa, West-ward Pharms Int, Barr, Dava Pharms Inc, Duramed Pharms Barr, Mylan, Sun Pharma Global, Zydus Pharms Usa Inc, Accord Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, and Sandoz Inc, and is included in thirty NDAs. It is available from twenty-one 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-nine suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for 081235

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 081235

Suppliers and Packaging for NDA: 081235

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 081235 ANDA Mylan Pharmaceuticals Inc. 0378-0014 0378-0014-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01)
METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 081235 ANDA Mylan Institutional Inc. 51079-670 51079-670-05 20 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-670-05) > 1 TABLET in 1 BLISTER PACK (51079-670-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:May 15, 1992TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
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Chinese Patent Office
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