Details for New Drug Application (NDA): 217314
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NDA 217314 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Gland Pharma Ltd, Hainan Poly Pharm, Norvium Bioscience, Novast Labs, Praxgen, and Sandoz, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the LEVOLEUCOVORIN CALCIUM profile page.
The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 217314
| Tradename: | LEVOLEUCOVORIN CALCIUM |
| Applicant: | Hainan Poly Pharm |
| Ingredient: | levoleucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 217314 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-340 | 14335-340-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-340-01) / 17.5 mL in 1 VIAL, SINGLE-DOSE |
| LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 217314 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-341 | 14335-341-01 | 1 VIAL in 1 CARTON (14335-341-01) / 25 INJECTION, SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | May 22, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | May 22, 2023 | TE: | AP | RLD: | No | ||||
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