Details for New Drug Application (NDA): 040335
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The generic ingredient in LEUCOVORIN CALCIUM PRESERVATIVE FREE 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 040335
Tradename: | LEUCOVORIN CALCIUM PRESERVATIVE FREE |
Applicant: | Hikma |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040335
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM PRESERVATIVE FREE | leucovorin calcium | INJECTABLE;INJECTION | 040335 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9552 | 0143-9552-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9552-01) / 17.5 mL in 1 VIAL |
LEUCOVORIN CALCIUM PRESERVATIVE FREE | leucovorin calcium | INJECTABLE;INJECTION | 040335 | ANDA | BluePoint Laboratories | 68001-418 | 68001-418-38 | 1 VIAL in 1 BOX, UNIT-DOSE (68001-418-38) / 17.5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 350MG BASE/VIAL | ||||
Approval Date: | Apr 20, 2000 | TE: | AP | RLD: | No |
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