Application 208032
- Type
- NDA
- Sponsor
- ST RENATUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KOVANAZE | OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.1MG/SPRAY;6MG/SPRAY | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69803-100 | Kovanaze | tetracaine hydrochloride and oxymetazoline hydrochloride | St. Renatus | NDA | Current |