Details for New Drug Application (NDA): 071198
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NDA 071198 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Fresenius Kabi Usa, Novast Labs, 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-eight NDAs. It is available from twelve suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.
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.
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 071198
| Tradename: | LEUCOVORIN CALCIUM |
| Applicant: | Barr |
| Ingredient: | leucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071198
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 071198 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0484 | 0555-0484-01 | 30 TABLET in 1 BOTTLE (0555-0484-01) |
| LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 071198 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0484 | 0555-0484-02 | 100 TABLET in 1 BOTTLE (0555-0484-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Sep 24, 1987 | TE: | AB | RLD: | No | ||||
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