Details for New Drug Application (NDA): 206519
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The generic ingredient in LATANOPROST is latanoprostene bunod. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the latanoprostene bunod profile page.
Summary for 206519
| Tradename: | LATANOPROST |
| Applicant: | Eugia Pharma |
| Ingredient: | latanoprost |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206519
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 206519 | ANDA | Aurobindo Pharma Limited | 65862-872 | 65862-872-25 | 1 BOTTLE in 1 CARTON (65862-872-25) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.005% | ||||
| Approval Date: | Sep 3, 2019 | TE: | RLD: | No | |||||
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