Application 019641
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERAZOL 3 | TERCONAZOLE | SUPPOSITORY;VAGINAL | 80MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50458-531 | Terazol 3 | TERCONAZOLE | Janssen Pharmaceuticals, Inc. | NDA | Current |