Details for New Drug Application (NDA): 216590
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NDA 216590 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 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 | Meitheal Pharmaceuticals Inc. | 71288-160 | 71288-160-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-160-10) / 5 mL in 1 VIAL, SINGLE-DOSE |
| LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 216590 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-161 | 71288-161-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-161-20) / 10 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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