Application 021753
- Type
- NDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIFFERIN | ADAPALENE | GEL;TOPICAL | 0.3% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0299-5918 | DIFFERIN | adapalene | Galderma Laboratories, L.P. | NDA | Current |
| 0299-5918 | DIFFERIN | adapalene | Galderma Laboratories, L.P. | NDA | Current |
| 0299-5918 | DIFFERIN | adapalene | Galderma Laboratories, L.P. | NDA | Current |
| 66993-884 | ADAPALENE | ADAPALENE | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 69007-918 | adapalene | adapalene | Owen Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77173 | SUPPL | 2024-01-02 |
| 77172 | SUPPL | 2024-01-02 |
| 77168 | SUPPL | 2023-12-29 |
| 77167 | SUPPL | 2023-12-29 |
| 71943 | SUPPL | 2022-08-29 |
| 71898 | SUPPL | 2022-08-26 |
| 28527 | SUPPL | 2014-06-18 |
| 16313 | SUPPL | 2012-02-27 |
| 37588 | SUPPL | 2010-09-07 |
| 28526 | SUPPL | 2010-09-07 |
| 42299 | ORIG | 2008-03-14 |
| 6125 | ORIG | 2007-07-05 |
| 16312 | ORIG | 2007-06-27 |