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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 089341


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NDA 089341 describes METHOTREXATE SODIUM, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, Norbrook, Pharmachemie Usa, Epic Pharma Llc, Accord Hlthcare, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma, Sun Pharm, Zydus Pharms, Eugia Pharma Speclts, Pharmachemie Bv, Sagent Pharms Inc, and Sandoz, and is included in thirty-seven NDAs. It is available from twenty suppliers. Additional details are available on the METHOTREXATE SODIUM profile page.

The generic ingredient in METHOTREXATE SODIUM is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.
Summary for 089341
Tradename:METHOTREXATE SODIUM
Applicant:Hikma
Ingredient:methotrexate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089341
Suppliers and Packaging for NDA: 089341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089341 ANDA Hikma Pharmaceuticals USA Inc. 0143-9518 0143-9518-01 1 VIAL in 1 BOX (0143-9518-01) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date:Sep 16, 1986TE:APRLD:No

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