TRIENTINE HYDROCHLORIDE
Trientine Hydrochloride Capsules, USP
Approved
Approval ID
5240e3de-54b6-4f22-9142-776f0e9ea1d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2022
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRIENTINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-683
Application NumberANDA216356
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIENTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2022
FDA Product Classification
INGREDIENTS (11)
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TRIENTINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: HC3NX54582
Classification: ACTIB
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT