Application 208399
- Type
- NDA
- Sponsor
- TERSERA THERAPS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VARUBI | ROLAPITANT HYDROCHLORIDE | EMULSION;INTRAVENOUS | EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69656-102 | Varubi | rolapitant | Tesaro, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64363 | SUPPL | 2020-08-21 |
| 64325 | SUPPL | 2020-08-20 |
| 56728 | ORIG | 2018-12-13 |
| 53699 | SUPPL | 2018-04-16 |
| 53685 | SUPPL | 2018-04-16 |
| 50229 | ORIG | 2017-10-30 |
| 50195 | ORIG | 2017-10-26 |