Application 215602
- Type
- NDA
- Sponsor
- AZURITY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLEQSUVY | BACLOFEN | SUSPENSION;ORAL | 25MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52652-6001 | FLEQSUVY | baclofen | Azurity Pharmaceuticals, Inc. | NDA | Current |