Application 208794
- Type
- NDA
- Sponsor
- LEXICON PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XERMELO | TELOTRISTAT ETIPRATE | TABLET;ORAL | EQ 250MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70183-125 | Xermelo | telotristat ethyl | Lexicon Pharmaceuticals, Inc. | NDA | Current |
| 70183-125 | Xermelo | telotristat ethyl | Lexicon Pharmaceuticals, Inc. | NDA | Current |
| 70183-125 | Xermelo | telotristat ethyl | Lexicon Pharmaceuticals, Inc. | NDA | Current |
| 70183-125 | Xermelo | telotristat ethyl | Lexicon Pharmaceuticals, Inc. | NDA | Current |
| 70183-125 | Xermelo | telotristat ethyl | Lexicon Pharmaceuticals, Inc. | NDA | Current |
| 70183-125 | Xermelo | telotristat ethyl | Lexicon Pharmaceuticals, Inc. | NDA | Current |
| 70720-125 | Xermelo | telotristat ethyl | TerSera Therapeutics LLC | NDA | Current |
| 70720-125 | Xermelo | telotristat ethyl | TerSera Therapeutics LLC | NDA | Current |
| 70720-125 | Xermelo | telotristat ethyl | TerSera Therapeutics LLC | NDA | Current |
| 70720-125 | Xermelo | telotristat ethyl | TerSera Therapeutics LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72163 | SUPPL | 2022-09-27 |
| 72160 | SUPPL | 2022-09-27 |
| 65107 | SUPPL | 2020-10-30 |
| 65044 | SUPPL | 2020-10-27 |
| 47848 | ORIG | 2017-04-04 |
| 47434 | ORIG | 2017-03-03 |
| 47385 | ORIG | 2017-03-01 |