Details for New Drug Application (NDA): 040716
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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 040716
Tradename: | METHOTREXATE SODIUM PRESERVATIVE FREE |
Applicant: | Accord Hlthcare |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Pharmacology for NDA: 040716
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 040716
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040716 | ANDA | Accord Healthcare, Inc. | 16729-277 | 16729-277-03 | 1 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL |
METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040716 | ANDA | Accord Healthcare, Inc. | 16729-277 | 16729-277-30 | 1 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | ||||
Approval Date: | Apr 30, 2007 | TE: | AP | RLD: | No |
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