Details for New Drug Application (NDA): 040263
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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 040263
Tradename: | METHOTREXATE SODIUM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Pharmacology for NDA: 040263
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 040263
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM | 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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | ||||
Approval Date: | Feb 26, 1999 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | ||||
Approval Date: | Feb 26, 1999 | TE: | RLD: | No |
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