Details for New Drug Application (NDA): 209706
NDA 209706 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 209706
| Tradename: | ALCAFTADINE |
| Applicant: | Gland |
| 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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