Details for New Drug Application (NDA): 210040
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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 210040
Tradename: | METHOTREXATE SODIUM |
Applicant: | Amneal Pharms |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Pharmacology for NDA: 210040
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 210040
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 210040 | ANDA | AvKARE | 42291-505 | 42291-505-01 | 100 TABLET in 1 BOTTLE (42291-505-01) |
METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 210040 | ANDA | AvPAK | 50268-527 | 50268-527-15 | 50 BLISTER PACK in 1 BOX (50268-527-15) / 1 TABLET in 1 BLISTER PACK (50268-527-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Dec 22, 2017 | TE: | RLD: | No |
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