Details for New Drug Application (NDA): 077200
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NDA 077200 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. Twenty-one 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. Twenty-one suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 077200
| Tradename: | ZADITOR |
| Applicant: | Alcon Pharms Ltd |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
Pharmacology for NDA: 077200
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077200
Suppliers and Packaging for NDA: 077200
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZADITOR | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077200 | ANDA | Alcon Laboratories, Inc. | 0065-4011 | 0065-4011-05 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER |
| ZADITOR | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077200 | ANDA | Alcon Laboratories, Inc. | 0065-4011 | 0065-4011-06 | 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE | ||||
| Approval Date: | Sep 2, 2008 | TE: | RLD: | No | |||||
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