Details for New Drug Application (NDA): 074544
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NDA 074544 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, Novast Labs, 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 are nine drug master file entries 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 are nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 074544
| Tradename: | LEUCOVORIN CALCIUM |
| Applicant: | Epic Pharma Llc |
| Ingredient: | leucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074544
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 074544 | ANDA | Epic Pharma LLC | 42806-133 | 42806-133-21 | 12 TABLET in 1 BOTTLE (42806-133-21) |
| LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 074544 | ANDA | Epic Pharma LLC | 42806-133 | 42806-133-24 | 24 TABLET in 1 BOTTLE (42806-133-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 28, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Aug 28, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | May 19, 2021 | TE: | AB | RLD: | No | ||||
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