Details for New Drug Application (NDA): 217387
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NDA 217387 describes LATANOPROSTENE BUNOD, which is a drug marketed by Gland and is included in one NDA. It is available from one supplier. Additional details are available on the LATANOPROSTENE BUNOD profile page.
The generic ingredient in LATANOPROSTENE BUNOD is latanoprostene bunod. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the latanoprostene bunod profile page.
The generic ingredient in LATANOPROSTENE BUNOD is latanoprostene bunod. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the latanoprostene bunod profile page.
Summary for 217387
| Tradename: | LATANOPROSTENE BUNOD |
| Applicant: | Gland |
| Ingredient: | latanoprostene bunod |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217387
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LATANOPROSTENE BUNOD | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 217387 | ANDA | Gland Pharma Limited | 68083-563 | 68083-563-01 | 1 BOTTLE in 1 CARTON (68083-563-01) / 2.5 mL in 1 BOTTLE |
| LATANOPROSTENE BUNOD | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 217387 | ANDA | Gland Pharma Limited | 68083-564 | 68083-564-01 | 1 BOTTLE in 1 CARTON (68083-564-01) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.024% | ||||
| Approval Date: | Apr 29, 2025 | TE: | AB | RLD: | No | ||||
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