Details for New Drug Application (NDA): 215913
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NDA 215913 describes SAFINAMIDE MESYLATE, which is a drug marketed by Aurobindo Pharma, MSN, Prinston Inc, and Zenara, and is included in four NDAs. Additional details are available on the SAFINAMIDE MESYLATE profile page.
The generic ingredient in SAFINAMIDE MESYLATE is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
The generic ingredient in SAFINAMIDE MESYLATE is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
Summary for 215913
| Tradename: | SAFINAMIDE MESYLATE |
| Applicant: | Zenara |
| Ingredient: | safinamide mesylate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jun 13, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 13, 2025 | TE: | AB | RLD: | No | ||||
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