Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020140
Company: ACROTECH BIOPHARMA
Company: ACROTECH BIOPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s026lbl.pdf | |
| 02/11/2020 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s025lbl.pdf | |
| 02/11/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s025lbl.pdf | |
| 01/08/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s024lbl.pdf | |
| 04/29/2011 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf | |
| 07/14/2008 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf | |
| 03/07/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf |