Drugs@FDA: FDA Approved Drug Products

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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
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
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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