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CAYSTON از شرکت GILEAD

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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

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050814lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814s000_cayston_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s000SumR.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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Letter (PDF)

Review (PDF)

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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