Application 212464
- Type
- ANDA
- Sponsor
- PERRIGO UK FINCO LTD PARTNERSHIP
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | GEL; TOPICAL | 0.3%;2.5% | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45802-853 | ADAPALENE AND BENZOYL PEROXIDE | adapalene and benzoyl peroxide | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 63629-9322 | ADAPALENE AND BENZOYL PEROXIDE | adapalene and benzoyl peroxide | Bryant Ranch Prepack | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 61151 | ORIG | 2019-12-04 |