Details for New Drug Application (NDA): 204059
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NDA 204059 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 204059
| Tradename: | KETOTIFEN FUMARATE |
| Applicant: | Unichem |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
Pharmacology for NDA: 204059
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 204059
Suppliers and Packaging for NDA: 204059
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 204059 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8715 | 68788-8715-5 | 1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5) / 5 mL in 1 BOTTLE, PLASTIC |
| KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 204059 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 76385-106 | 76385-106-17 | 1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE | ||||
| Approval Date: | Jun 1, 2020 | TE: | RLD: | No | |||||
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