Application 212384
- Type
- ANDA
- Sponsor
- ENCUBE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | OINTMENT;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21922-024 | Triamcinolone Acetonide | Triamcinolone Acetonide Ointment USP, 0.05% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-024 | Triamcinolone Acetonide | Triamcinolone Acetonide Ointment USP, 0.05% | Encube Ethicals Private Limited | ANDA | Current |
| 51862-290 | triamcinolone acetonide | triamcinolone acetonide | Mayne Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61130 | ORIG | 2019-12-03 |