Details for New Drug Application (NDA): 021996
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NDA 021996 describes CHILDREN'S ALAWAY, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from thirteen suppliers. Additional details are available on the CHILDREN'S ALAWAY profile page.
The generic ingredient in CHILDREN'S ALAWAY is ketotifen fumarate. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
The generic ingredient in CHILDREN'S ALAWAY is ketotifen fumarate. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 021996
| Tradename: | CHILDREN'S ALAWAY |
| Applicant: | Bausch And Lomb |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021996
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 021996
Suppliers and Packaging for NDA: 021996
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALAWAY | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 021996 | NDA | Walgreen Company | 0363-0038 | 0363-0038-05 | 1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE |
| ALAWAY | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 021996 | NDA | Walgreen Company | 0363-0038 | 0363-0038-10 | 1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE | ||||
| Approval Date: | Dec 1, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE | ||||
| Approval Date: | Feb 11, 2015 | TE: | RLD: | Yes | |||||
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