Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202497
Company: ACROTECH
Company: ACROTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MARQIBO KIT | VINCRISTINE SULFATE | 5MG/5ML (1MG/ML) | INJECTABLE, LIPOSOMAL;INTRAVENOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/09/2012 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202497Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202497_marqibo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202497Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2022 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202497Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202497Orig1s013ltr.pdf | |
| 06/08/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202497s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202497Orig1s011ltr.pdf | |
| 01/03/2020 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202497s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202497Orig1s010ltr.pdf | |
| 09/18/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/2022 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202497Orig1s013lbl.pdf | |
| 03/15/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202497Orig1s013lbl.pdf | |
| 06/08/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202497s011lbl.pdf | |
| 01/03/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202497s010lbl.pdf | |
| 08/09/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf |