اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CUROSURF از شرکت CHIESI USA INC
Biologic License Application (BLA): 020744
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/17/2021 | SUPPL-43 | Supplement |
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 |
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 |
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 |
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 |
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 |
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 |
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