Details for New Drug Application (NDA): 209706
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The generic ingredient in ALCAFTADINE is alcaftadine. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alcaftadine profile page.
Summary for 209706
Tradename: | ALCAFTADINE |
Applicant: | Gland Pharma Ltd |
Ingredient: | alcaftadine |
Patents: | 0 |
Pharmacology for NDA: 209706
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 209706
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 209706 | ANDA | Gland Pharma Limited | 68083-649 | 68083-649-01 | 1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE |
ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 209706 | ANDA | Gland Pharma Limited | 68083-649 | 68083-649-02 | 2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.25% | ||||
Approval Date: | Mar 1, 2024 | TE: | RLD: | No |
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