CUVRIOR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Orphalan Sa. The primary component is Trientine Tetrahydrochloride.
| Product ID | 81802-001_59a6b94d-79f1-4ed9-9c61-e44f907b1e2b |
| NDC | 81802-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CUVRIOR |
| Generic Name | Trientine Tetrahydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-09-14 |
| Marketing Category | NDA / |
| Application Number | NDA215760 |
| Labeler Name | Orphalan SA |
| Substance Name | TRIENTINE TETRAHYDROCHLORIDE |
| Active Ingredient Strength | 300 mg/1 |
| Pharm Classes | Metal Chelating Activity [MoA], Metal Chelator [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-09-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CUVRIOR 97059705 not registered Live/Pending |
ORPHALAN 2021-10-05 |
![]() CUVRIOR 79349657 not registered Live/Pending |
ORPHALAN 2022-06-29 |