Details for New Drug Application (NDA): 218444
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NDA 218444 describes SIPONIMOD, which is a drug marketed by Aurobindo Pharma Ltd and Riconpharma Llc and is included in two NDAs. Additional details are available on the SIPONIMOD profile page.
The generic ingredient in SIPONIMOD is siponimod. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the siponimod profile page.
The generic ingredient in SIPONIMOD is siponimod. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the siponimod profile page.
Summary for 218444
| Tradename: | SIPONIMOD |
| Applicant: | Riconpharma Llc |
| Ingredient: | siponimod |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 0.25MG BASE | ||||
| Approval Date: | Apr 22, 2025 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Apr 22, 2025 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Apr 22, 2025 | TE: | RLD: | No | |||||
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