Application 213006
- Type
- NDA
- Sponsor
- UROVANT SCIENCES GMBH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GEMTESA | VIBEGRON | TABLET;ORAL | 75MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73336-075 | GEMTESA | vibegron | Urovant Sciences, Inc. | NDA | Current |
| 73336-075 | GEMTESA | vibegron | Urovant Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81300 | SUPPL | 2024-12-19 |
| 80636 | SUPPL | 2024-12-19 |
| 79845 | SUPPL | 2024-12-19 |
| 79851 | SUPPL | 2024-10-10 |
| 65934 | ORIG | 2021-01-19 |
| 65762 | ORIG | 2020-12-28 |
| 65733 | ORIG | 2020-12-23 |