Details for New Drug Application (NDA): 077958
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NDA 077958 describes KETOTIFEN FUMARATE, which is a drug marketed by Apotex Inc, Bayshore Pharms Llc, and Sentiss, and is included in three NDAs. It is available from four 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. Eighteen 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. Eighteen 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 | Proficient Rx LP | 71205-115 | 71205-115-05 | 1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPER |
| KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077958 | ANDA | Armas Pharmaceuticals Inc. | 72485-617 | 72485-617-10 | 1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 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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