Details for New Drug Application (NDA): 210659
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The generic ingredient in ALCAFTADINE is alcaftadine. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the alcaftadine profile page.
Summary for 210659
Tradename: | ALCAFTADINE |
Applicant: | Eugia Pharma |
Ingredient: | alcaftadine |
Patents: | 0 |
Pharmacology for NDA: 210659
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 210659
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 210659 | ANDA | Aurohealth LLC | 58602-605 | 58602-605-40 | 1 BOTTLE in 1 CARTON (58602-605-40) / 5 mL in 1 BOTTLE |
ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 210659 | ANDA | Aurohealth LLC | 58602-605 | 58602-605-42 | 2 BOTTLE in 1 CARTON (58602-605-42) / 5 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.25% | ||||
Approval Date: | Jun 23, 2023 | TE: | RLD: | No |
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