Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050682
Company: RECORDATI RARE
Company: RECORDATI RARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COSMEGEN | DACTINOMYCIN | 0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/10/1964 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/15/2018 | SUPPL-34 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050682Orig1s034ltr.pdf | |
| 08/15/2018 | SUPPL-33 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050682Orig1s033ltr.pdf | |
| 04/07/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2012 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf | |
| 02/03/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf | |
| 03/13/2009 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050682s025ltr.pdf | |
| 08/17/2005 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050682s022ltr.pdf |
| 11/30/2004 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50682s021ltr.pdf |
| 03/19/2003 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50682slr020ltr.pdf |
| 10/28/2002 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50682slr019ltr.pdf |
| 02/14/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/08/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/1998 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/06/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/17/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/22/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/15/2018 | SUPPL-34 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s034lbl.pdf | |
| 08/15/2018 | SUPPL-33 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf | |
| 02/03/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf | |
| 02/03/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf | |
| 03/13/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf |