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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021658
Company: COVIS

Summary Review

Products on NDA 021658

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALVESCO	CICLESONIDE	0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
ALVESCO	CICLESONIDE	0.16MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021658

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021658s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021658s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021658Orig1s011ltr.pdf
04/22/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/07/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/17/2012	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s006ltr.pdf
11/19/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s005ltr.pdf
12/22/2008	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s002ltr.pdf
10/10/2008	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 021658

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021658s011lbl.pdf
12/17/2012	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf
11/19/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf
12/22/2008	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf
01/10/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf

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