Details for New Drug Application (NDA): 040054
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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 040054
Tradename: | METHOTREXATE SODIUM |
Applicant: | Hikma |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Pharmacology for NDA: 040054
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 040054
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 040054 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-4550 | 0054-4550-15 | 36 TABLET in 1 BOTTLE, PLASTIC (0054-4550-15) |
METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 040054 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-4550 | 0054-4550-25 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Aug 1, 1994 | TE: | AB | RLD: | No |
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