Details for New Drug Application (NDA): 215063
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NDA 215063 describes LIFITEGRAST, which is a drug marketed by Eugia Pharma, Ingenus Pharms Llc, and Micro Labs, and is included in three NDAs. It is available from one supplier. Additional details are available on the LIFITEGRAST profile page.
The generic ingredient in LIFITEGRAST is lifitegrast. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
The generic ingredient in LIFITEGRAST is lifitegrast. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
Summary for 215063
| Tradename: | LIFITEGRAST |
| Applicant: | Eugia Pharma |
| Ingredient: | lifitegrast |
| Patents: | 0 |
Pharmacology for NDA: 215063
| Mechanism of Action | Lymphocyte Function-Associated Antigen-1 Antagonists |
Suppliers and Packaging for NDA: 215063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIFITEGRAST | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 215063 | ANDA | Aurobindo Pharma Limited | 59651-450 | 59651-450-60 | 60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 5% | ||||
| Approval Date: | Nov 7, 2023 | TE: | RLD: | No | |||||
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