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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050814
Company: GILEAD

Summary Review

Products on NDA 050814

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050814

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

Labels for NDA 050814

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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