Drugs@FDA: FDA-Approved Drugs
Company: CHIESI USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CUROSURF | PORACTANT ALFA | 80MG/ML | SUSPENSION;INTRATRACHEAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
11/18/1999 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20744ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20744_Curosurf.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/17/2021 | SUPPL-43 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020744s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020744Orig1s043ltr.pdf | |
12/16/2019 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020744s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020744Orig1s040ltr.pdf | |
11/01/2016 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
11/03/2016 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
05/04/2015 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
10/15/2014 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
10/10/2014 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020744s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020744Orig1s028ltr.pdf | |
02/12/2014 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
04/15/2013 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
04/15/2013 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
09/26/2008 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020744s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020744s019ltr.pdf | |
12/13/2002 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
04/17/2002 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
06/03/2002 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
04/05/2002 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
03/01/2002 | SUPPL-4 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20744s4ltr.pdf |
11/21/2002 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
02/17/2004 | SUPPL-2 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20744scs002ltr.pdf |
06/19/2001 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/17/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020744s043lbl.pdf | |
05/17/2021 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020744s043lbl.pdf | |
12/16/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020744s040lbl.pdf | |
10/10/2014 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020744s028lbl.pdf | |
09/26/2008 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020744s019lbl.pdf | |
11/18/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf |