Application 213969
- Type
- NDA
- Sponsor
- EIGER BIOPHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOKINVY | LONAFARNIB | CAPSULE;ORAL | 50MG | Yes | No |
| 002 | ZOKINVY | LONAFARNIB | CAPSULE;ORAL | 75MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 73079-050 | Zokinvy | lonafarnib | Eiger BioPharmaceuticals, Inc. | NDA | Current |
| 73079-050 | Lonafarnib | lonafarnib | Eiger BioPharmaceuticals, Inc. | NDA | Current |
| 73079-075 | Zokinvy | lonafarnib | Eiger BioPharmaceuticals, Inc. | NDA | Current |
| 73079-075 | Lonafarnib | lonafarnib | Eiger BioPharmaceuticals, Inc. | NDA | Current |