NDC 81802-001

CUVRIOR

Trientine Tetrahydrochloride

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 ID81802-001_59a6b94d-79f1-4ed9-9c61-e44f907b1e2b
NDC81802-001
Product TypeHuman Prescription Drug
Proprietary NameCUVRIOR
Generic NameTrientine Tetrahydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-09-14
Marketing CategoryNDA /
Application NumberNDA215760
Labeler NameOrphalan SA
Substance NameTRIENTINE TETRAHYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesMetal Chelating Activity [MoA], Metal Chelator [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 81802-001-72

9 CARTON in 1 CARTON (81802-001-72) > 1 BLISTER PACK in 1 CARTON (81802-001-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2022-09-14
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [CUVRIOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CUVRIOR
CUVRIOR
97059705 not registered Live/Pending
ORPHALAN
2021-10-05
CUVRIOR
CUVRIOR
79349657 not registered Live/Pending
ORPHALAN
2022-06-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.