Application 022259
- Type
- NDA
- Sponsor
- HILL DERMACEUTICALS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOLAK | FLUOROURACIL | CREAM;TOPICAL | 4% | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 28105-421 | TOLAK | FLUOROURACIL | HILL DERMACEUTICALS, INC. | NDA | Current |
| 28105-421 | TOLAK | FLUOROURACIL | HILL DERMACEUTICALS, INC. | NDA | Current |
| 28105-421 | TOLAK | FLUOROURACIL | HILL DERMACEUTICALS, INC. | NDA | Current |
| 64370-421 | TOLAK | FLUOROURACIL | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-421 | TOLAK | FLUOROURACIL | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-421 | TOLAK | FLUOROURACIL | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |