Application 020001
- Type
- NDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAPEX | FLUOCINOLONE ACETONIDE | SHAMPOO;TOPICAL | 0.01% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0299-5500 | Capex | fluocinolone acetonide | Galderma Laboratories, L.P. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 19925 | SUPPL | 2015-12-18 |