Details for New Drug Application (NDA): 077200
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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 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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