Application 207133
- Type
- ANDA
- Sponsor
- PERRIGO UK FINCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLURANDRENOLIDE | FLURANDRENOLIDE | LOTION;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-928 | Flurandrenolide | Flurandrenolide | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-928 | Flurandrenolide | Flurandrenolide | Perrigo New York Inc | ANDA | Current |
| 45802-928 | Flurandrenolide | Flurandrenolide | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 63629-8657 | Flurandrenolide | Flurandrenolide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8657 | Flurandrenolide | Flurandrenolide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8657 | Flurandrenolide | Flurandrenolide | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45189 | ORIG | 2016-08-30 |