Details for New Drug Application (NDA): 207226
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The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 207226
Tradename: | LEUCOVORIN CALCIUM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207226
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 207226 | ANDA | Fresenius Kabi USA, LLC | 63323-631 | 63323-631-50 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-50) / 50 mL in 1 VIAL, SINGLE-USE |
LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 207226 | ANDA | Fresenius Kabi USA, LLC | 63323-631 | 63323-631-10 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Jul 27, 2018 | TE: | RLD: | No |
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