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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021066
Company: ALCON PHARMA

Products on NDA 021066

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZADITOR	KETOTIFEN FUMARATE	EQ 0.025% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-066_Zaditor.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/03/2012	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021066Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021066s018ltr.pdf
07/09/2008	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021066s013ltr.pdf
09/21/2006	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
10/19/2006	SUPPL-11	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021066s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021066s011ltr.pdf
10/04/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
07/20/2001	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21066s4lbl.pdf
12/26/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/24/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/08/2000	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021066Orig1s001.pdf

Labels for NDA 021066

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/03/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021066Orig1s018lbl.pdf
10/19/2006	SUPPL-11	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021066s011lbl.pdf
07/20/2001	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21066s4lbl.pdf
07/02/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21066lbl.pdf

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