Details for New Drug Application (NDA): 214302
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NDA 214302 describes SELEXIPAG, which is a drug marketed by Alembic and Zydus Lifesciences and is included in two NDAs. Additional details are available on the SELEXIPAG profile page.
The generic ingredient in SELEXIPAG is selexipag. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.
The generic ingredient in SELEXIPAG is selexipag. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.
Summary for 214302
| Tradename: | SELEXIPAG |
| Applicant: | Zydus Lifesciences |
| Ingredient: | selexipag |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | Dec 21, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.4MG | ||||
| Approval Date: | Dec 21, 2022 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Dec 21, 2022 | TE: | RLD: | No | |||||
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