Details for New Drug Application (NDA): 077958
NDA 077958 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 is one drug master file entry for this compound. Twenty 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 077958
| Tradename: | KETOTIFEN FUMARATE |
| Applicant: | Sentiss |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
Pharmacology for NDA: 077958
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077958
Suppliers and Packaging for NDA: 077958
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077958 | ANDA | Preferred Pharmaceuticals Inc. | 68788-4084 | 68788-4084-5 | 1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER |
| KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077958 | ANDA | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0124 | 70000-0124-1 | 1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 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: | Jul 26, 2007 | TE: | RLD: | No | |||||
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