Acthrel
ACTHREL (corticorelin ovine triflutate for injection)
Approved
Approval ID
3c39dcea-d8f7-8594-01e6-24e8d6fa4d2f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2021
Manufacturers
FDA
Ferring Pharmaceuticals Inc.
DUNS: 103722955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Corticorelin ovine triflutate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55566-0302
Application NumberBLA020162
Product Classification
M
Marketing Category
C73585
G
Generic Name
Corticorelin ovine triflutate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 12, 2021
FDA Product Classification
INGREDIENTS (4)
ASCORBIC ACIDInactive
Quantity: 0.88 mg in 2 mL
Code: PQ6CK8PD0R
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
CORTICORELIN OVINE TRIFLUTATEActive
Quantity: 100 ug in 2 mL
Code: 56X54T817Q
Classification: ACTIM