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Details for New Drug Application (NDA): 020140
NDA 020140 describes FUSILEV, which is a drug marketed by Spectrum Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the FUSILEV profile page.
The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 020140
| Tradename: | FUSILEV |
| Applicant: | Spectrum Pharms |
| Ingredient: | levoleucovorin calcium |
| Patents: | 1 |
Medical Subject Heading (MeSH) Categories for 020140
Suppliers and Packaging for NDA: 020140
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140 | NDA | Spectrum Pharmaceuticals, Inc. | 68152-101 | 68152-101-00 | 1 VIAL in 1 CARTON (68152-101-00) > 5 mL in 1 VIAL |
| FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140 | NDA | Spectrum Pharmaceuticals, Inc. | 68152-101 | 68152-101-00 | 1 VIAL in 1 CARTON (68152-101-00) > 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Mar 7, 2008 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 29, 2018 | ||||||||
| Regulatory Exclusivity Use: | FOR USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Mar 7, 2022 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Apr 29, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 29, 2018 | ||||||||
| Regulatory Exclusivity Use: | FOR USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER | ||||||||
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