Details for New Drug Application (NDA): 213511
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NDA 213511 describes ELUXADOLINE, which is a drug marketed by Aurobindo Pharma and Zydus Pharms and is included in two NDAs. Additional details are available on the ELUXADOLINE profile page.
The generic ingredient in ELUXADOLINE is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
The generic ingredient in ELUXADOLINE is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
Summary for 213511
| Tradename: | ELUXADOLINE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | eluxadoline |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Jun 2, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 2, 2026 | TE: | AB | RLD: | No | ||||
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