Details for New Drug Application (NDA): 210659
NDA 210659 describes ALCAFTADINE, which is a drug marketed by Alembic, Eugia Pharma, and Gland, and is included in three NDAs. It is available from three suppliers. Additional details are available on the ALCAFTADINE profile page.
The generic ingredient in ALCAFTADINE is alcaftadine. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the alcaftadine profile page.
The generic ingredient in ALCAFTADINE is alcaftadine. There is one drug master file entry 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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