Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021066
Company: ALCON PHARMA
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ZADITOR KETOTIFEN FUMARATE EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
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
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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