Application 201750
- Type
- ANDA
- Sponsor
- HANSAMED INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ULTACAN FORTE | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52120-100 | Ultacan Forte | articaine hydrochloride, epinephrine bitartrate | HANSAmed, Inc. | ANDA | Current |