Application 022259
- Type
- NDA
- Sponsor
- HILL DERMACEUTICALS
Application Products#
Product, Drug, Ingredient table| 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 table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72011 | SUPPL | 2022-09-02 |
| 71990 | SUPPL | 2022-09-01 |
| 46064 | ORIG | 2016-10-26 |
| 46063 | ORIG | 2016-10-26 |
| 38457 | ORIG | 2015-09-23 |
| 29486 | ORIG | 2015-09-22 |