Application 020886
- Type
- NDA
- Sponsor
- CONCORDIA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PANRETIN | ALITRETINOIN | GEL;TOPICAL | EQ 0.1% BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59212-601 | PANRETIN | alitretinoin | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-601 | PANRETIN | alitretinoin | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-601 | PANRETIN | alitretinoin | Concordia Pharmaceuticals Inc. | NDA | Current |
| 62856-601 | Panretin | Alitretinoin | Eisai Inc. | NDA | Current |
| 62856-601 | Panretin | Alitretinoin | Eisai Inc. | NDA | Current |