Details for New Drug Application (NDA): 072733
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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 072733
Tradename: | LEUCOVORIN CALCIUM |
Applicant: | Hikma |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 072733
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 072733 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-4496 | 0054-4496-13 | 30 TABLET in 1 BOTTLE (0054-4496-13) |
LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 072733 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-4496 | 0054-4496-25 | 100 TABLET in 1 BOTTLE (0054-4496-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Feb 22, 1993 | TE: | AB | RLD: | No |
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