← FDA Drug Approvals (Drugs@FDA)
XERMELO
NDA · New Drug Application · Sponsor: TERSERA · Approved 2017-02-28
Drug application
- FDA Application #
NDA208794
- Application type
- New Drug Application
- Brand name
- XERMELO
- Generic name
- TELOTRISTAT ETHYL
- Active ingredients
- TELOTRISTAT ETIPRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- TERSERA
- Manufacturer
- Lexicon Pharmaceuticals, Inc.
- First approval
- 2017-02-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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