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
CAYSTON از شرکت GILEAD
New Drug Application (NDA): 050814
Company: GILEAD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAYSTON | AZTREONAM | 75MG/VIAL | FOR SOLUTION;INHALATION | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/22/2010 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050814lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/20/2019 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050814s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050814Orig1s023ltr.pdf |
||
| 02/11/2019 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050814s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050814Orig1s021ltr.pdf |
||
| 12/22/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050814Orig1s016ltr.pdf |
|
| 01/12/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2012 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050814s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050814Orig1s007ltr.pdf |
||
| 08/20/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/20/2019 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050814s023lbl.pdf | |
| 02/11/2019 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050814s021lbl.pdf | |
| 09/24/2012 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050814s007lbl.pdf | |
| 02/22/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050814lbl.pdf |
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