Details for New Drug Application (NDA): 206263
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NDA 206263 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 206263
| Tradename: | LEVOLEUCOVORIN CALCIUM |
| Applicant: | Hikma |
| Ingredient: | levoleucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206263
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 206263 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9558 | 0143-9558-01 | 1 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Jun 16, 2016 | TE: | RLD: | No | |||||
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