Application 020985
- Type
- NDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARAC | FLUOROURACIL | CREAM;TOPICAL | 0.5% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0187-5200 | Carac | fluorouracil | Bausch Health US LLC | NDA | Current |
| 0187-5200 | Carac | fluorouracil | Bausch Health Americas, Inc. | NDA | Current |
| 0187-5200 | Carac | fluorouracil | Bausch Health US, LLC | NDA | Current |
| 0187-5200 | Carac | fluorouracil | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0378-8078 | Fluorouracil Cream | fluorouracil | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-8078 | Fluorouracil Cream | fluorouracil | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8078 | Fluorouracil Cream | fluorouracil | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8078 | Fluorouracil Cream | fluorouracil | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-8078 | Fluorouracil Cream | fluorouracil | Mylan Pharmaceuticals Inc. | NDA | Current |
| 66530-258 | Fluorouracil | fluorouracil | Spear Dermatology Products Inc | NDA AUTHORIZED GENERIC | Current |
| 66530-258 | Fluorouracil | fluorouracil | Spear Dermatology Products Inc | NDA AUTHORIZED GENERIC | Current |
| 66530-258 | Fluorouracil | fluorouracil | Spear Dermatology Products Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85814 | SUPPL | 2026-05-04 |
| 85813 | SUPPL | 2026-05-04 |
| 71161 | SUPPL | 2022-05-27 |
| 71157 | SUPPL | 2022-05-27 |
| 14086 | SUPPL | 2003-12-29 |
| 26376 | SUPPL | 2003-12-19 |
| 41861 | ORIG | 2003-04-25 |
| 35787 | ORIG | 2000-10-27 |
| 26375 | ORIG | 2000-10-27 |