Application 018052
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | GYNE-LOTRIMIN | CLOTRIMAZOLE | CREAM;VAGINAL | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |