Application 021383
- Type
- NDA
- Sponsor
- DENTSPLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CITANEST FORTE DENTAL | EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.005MG/ML;4% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66312-540 | Citanest Forte | prilocaine hydrochloride and epinephrine bitartrate | Dentsply Pharmaceutical Inc. | NDA | Current |