Details for New Drug Application (NDA): 071199
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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 071199
Tradename: | LEUCOVORIN CALCIUM |
Applicant: | Barr |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 071199
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 071199 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0485 | 0555-0485-04 | 500 TABLET in 1 BOTTLE (0555-0485-04) |
LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 071199 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0485 | 0555-0485-27 | 25 TABLET in 1 BOTTLE (0555-0485-27) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Sep 24, 1987 | TE: | AB | RLD: | No |
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