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ZADITOR | KETOTIFEN FUMARATE | EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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