← FDA Drug Approvals (Drugs@FDA)
OLYSIO
NDA · New Drug Application · Sponsor: JANSSEN PRODS · Approved 2013-11-22
Drug application
- FDA Application #
NDA205123
- Application type
- New Drug Application
- Brand name
- OLYSIO
- Generic name
- Simeprevir Sodium
- Active ingredients
- SIMEPREVIR SODIUM
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- JANSSEN PRODS
- First approval
- 2013-11-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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