Details for New Drug Application (NDA): 220225
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NDA 220225 describes METHOTREXATE SODIUM, which is a drug marketed by Abraxis Pharm, Alembic, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hikma, Hospira, Norbrook, Pharmachemie Usa, Epic Pharma Llc, Accord Hlthcare, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Elite Labs Inc, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma Intl, Sun Pharm, Zydus Pharms, Caplin One Labs, Eugia Pharma Speclts, Extrovis, Pharmachemie Bv, and Sagent Pharms Inc, and is included in forty-one NDAs. It is available from twenty-four 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.
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 220225
| Tradename: | METHOTREXATE SODIUM |
| Applicant: | Alembic |
| Ingredient: | methotrexate sodium |
| Patents: | 0 |
Pharmacology for NDA: 220225
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 220225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 220225 | ANDA | Alembic Pharmaceuticals Limited | 46708-711 | 46708-711-05 | 5 VIAL, MULTI-DOSE in 1 CARTON (46708-711-05) / 2 mL in 1 VIAL, MULTI-DOSE (46708-711-01) |
| METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 220225 | ANDA | Alembic Pharmaceuticals Limited | 46708-712 | 46708-712-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-712-01) / 40 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Apr 15, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Apr 15, 2026 | TE: | AP | RLD: | No | ||||
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