Details for New Drug Application (NDA): 207548
NDA 207548 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Gland, Hainan Poly Pharm, Ingenus Pharms Llc, Pharmobedient, Quagen, 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 207548
| Tradename: | LEVOLEUCOVORIN CALCIUM |
| Applicant: | Amneal |
| Ingredient: | levoleucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207548
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 207548 | ANDA | Amneal Pharmaceuticals LLC | 70121-1572 | 70121-1572-1 | 1 VIAL in 1 CARTON (70121-1572-1) / 17.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Sep 8, 2017 | TE: | RLD: | No | |||||
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