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Application 206940
- Type
- NDA
- Sponsor
- ALLERGAN HOLDINGS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VIBERZI | ELUXADOLINE | TABLET;ORAL | 75MG | Yes | No |
| 002 | VIBERZI | ELUXADOLINE | TABLET;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61874-075 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-075 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-075 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-075 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-075 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-075 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-100 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-100 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-100 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-100 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-100 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |
| 61874-100 | Viberzi | Eluxadoline | Allergan, Inc. | NDA | Current |