Details for New Drug Application (NDA): 020140
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NDA 020140 describes FUSILEV, which is a drug marketed by Acrotech Biopharma 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 020140
| Tradename: | FUSILEV |
| Applicant: | Acrotech Biopharma |
| Ingredient: | levoleucovorin calcium |
| Patents: | 1 |
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 | Acrotech Biopharma Inc | 72893-009 | 72893-009-01 | 1 VIAL in 1 CARTON (72893-009-01) / 5 mL in 1 VIAL |
| FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140 | NDA | Acrotech Biopharma Inc | 72893-009 | 72893-009-01 | 1 VIAL in 1 CARTON (72893-009-01) / 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 | ||||
| Patent: | ⤷ Try a Trial | 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Strength | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 29, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2022 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 29, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2022 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 020140
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | Apr 29, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Acrotech Biopharma | FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140-001 | Mar 7, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-002 | Apr 29, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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