Details for New Drug Application (NDA): 040843
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The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 040843
Tradename: | METHOTREXATE SODIUM PRESERVATIVE FREE |
Applicant: | Pharmachemie Bv |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Pharmacology for NDA: 040843
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 040843
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040843 | ANDA | Teva Parenteral Medicines, Inc. | 0703-3671 | 0703-3671-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040843 | ANDA | Teva Parenteral Medicines, Inc. | 0703-3675 | 0703-3675-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3675-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | ||||
Approval Date: | Jan 11, 2010 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | ||||
Approval Date: | Jan 11, 2010 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | ||||
Approval Date: | Feb 27, 2012 | TE: | RLD: | No |
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