Details for New Drug Application (NDA): 207812
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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 207812
Tradename: | METHOTREXATE SODIUM |
Applicant: | Zydus Pharms |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207812
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 207812
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 207812 | ANDA | Major Pharmaceuticals | 0904-7141 | 0904-7141-10 | 20 BLISTER PACK in 1 CARTON (0904-7141-10) / 1 TABLET in 1 BLISTER PACK |
METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 207812 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-775 | 68382-775-01 | 100 TABLET in 1 BOTTLE (68382-775-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jan 13, 2017 | TE: | AB | RLD: | No |
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