Details for New Drug Application (NDA): 071199
NDA 071199 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Gland, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Fresenius Kabi Usa, Ingenus Pharms Llc, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, Xanodyne Pharm, Am Regent, Mylan Labs Ltd, Sagent Pharms, and Sagent Pharms Inc, and is included in forty-nine NDAs. It is available from fourteen suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.
The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There is one drug master file entry for this compound. Seventeen 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 |
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 | 0555-0485-27 | 25 TABLET in 1 BOTTLE (0555-0485-27) |
| LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 071199 | ANDA | American Health Packaging | 60687-227 | 60687-227-94 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-227-94) / 1 TABLET in 1 BLISTER PACK (60687-227-11) |
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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