Details for New Drug Application (NDA): 021066
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NDA 021066 describes ZADITOR, which is a drug marketed by Alcon Pharma and Alcon Pharms Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the ZADITOR profile page.
The generic ingredient in ZADITOR is ketotifen fumarate. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
The generic ingredient in ZADITOR is ketotifen fumarate. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 021066
| Tradename: | ZADITOR |
| Applicant: | Alcon Pharma |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021066
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 19, 2006 | TE: | RLD: | Yes | |||||
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