Details for New Drug Application (NDA): 020140
✉ Email this page to a colleague
The generic ingredient in FUSILEV 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 020140
Tradename: | FUSILEV |
Applicant: | Acrotech Biopharma |
Ingredient: | levoleucovorin calcium |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020140
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
Approval Date: | Mar 7, 2008 | TE: | RLD: | Yes |
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Strength | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
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| Strength | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
Expired US Patents for NDA 020140
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Acrotech Biopharma | FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140-001 | Mar 7, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | Apr 29, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-002 | Apr 29, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription