Details for New Drug Application (NDA): 215739
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NDA 215739 describes SAFINAMIDE MESYLATE, which is a drug marketed by Aurobindo Pharma and Prinston Inc and is included in two 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 215739
| Tradename: | SAFINAMIDE MESYLATE |
| Applicant: | Prinston Inc |
| Ingredient: | safinamide mesylate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Apr 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 25, 2024 | TE: | AB | RLD: | No | ||||
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