Details for New Drug Application (NDA): 040266
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The generic ingredient in METHOTREXATE 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 040266
Tradename: | METHOTREXATE PRESERVATIVE FREE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | methotrexate sodium |
Patents: | 0 |
Pharmacology for NDA: 040266
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 040266
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040266 | ANDA | Fresenius Kabi USA, LLC | 63323-122 | 63323-122-50 | 1 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Feb 26, 1999 | TE: | AP | RLD: | No |
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