Application 215422
- Type
- NDA
- Sponsor
- SAOL THERAPS RES LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LYVISPAH | BACLOFEN | GRANULE;ORAL | 5MG | Yes | No |
| 002 | LYVISPAH | BACLOFEN | GRANULE;ORAL | 10MG | Yes | No |
| 003 | LYVISPAH | BACLOFEN | GRANULE;ORAL | 20MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70257-412 | Lyvispah | baclofen | Saol Therapeutics Inc | NDA | Current |
| 70257-414 | Lyvispah | baclofen | Saol Therapeutics Inc | NDA | Current |
| 70257-416 | Lyvispah | baclofen | Saol Therapeutics Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71662 | ORIG | 2022-07-29 |
| 69398 | ORIG | 2021-11-23 |
| 69397 | ORIG | 2021-11-23 |