Details for New Drug Application (NDA): 216590
NDA 216590 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 216590
| Tradename: | LEUCOVORIN CALCIUM |
| Applicant: | Meitheal |
| Ingredient: | leucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216590
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 216590 | ANDA | BluePoint Laboratories | 68001-648 | 68001-648-36 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-648-36) / 10 mL in 1 VIAL, SINGLE-DOSE |
| LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 216590 | ANDA | BluePoint Laboratories | 68001-649 | 68001-649-37 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-649-37) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Jul 19, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Jul 19, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
| Approval Date: | Jul 19, 2023 | TE: | AP | RLD: | No | ||||
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