Details for New Drug Application (NDA): 040266
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NDA 040266 describes METHOTREXATE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa and Hospira and is included in three NDAs. It is available from two suppliers. Additional details are available on the METHOTREXATE PRESERVATIVE FREE profile page.
The generic ingredient in METHOTREXATE PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
The generic ingredient in METHOTREXATE PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Thirty 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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