Details for New Drug Application (NDA): 077354
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NDA 077354 describes KETOTIFEN FUMARATE, which is a drug marketed by Apotex Inc, Sentiss, and Unichem, and is included in three NDAs. It is available from six suppliers. Additional details are available on the KETOTIFEN FUMARATE profile page.
The generic ingredient in KETOTIFEN FUMARATE is ketotifen fumarate. There are five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
The generic ingredient in KETOTIFEN FUMARATE is ketotifen fumarate. There are five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 077354
| Tradename: | KETOTIFEN FUMARATE |
| Applicant: | Apotex Inc |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 077354
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE | ||||
| Approval Date: | May 9, 2006 | TE: | RLD: | No | |||||
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