COLLAGENASE SANTYL
COLLAGENASE SANTYL ointment 250 units/g [SMITH & NEPHEW, INC]
Approved
Approval ID
6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2019
Manufacturers
FDA
SMITH & NEPHEW, INC
DUNS: 827731451
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COLLAGENASE SANTYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50484-010
Application NumberBLA101995
Product Classification
M
Marketing Category
C73585
G
Generic Name
COLLAGENASE SANTYL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 24, 2017
FDA Product Classification
INGREDIENTS (2)
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMActive
Quantity: 250 [arb'U] in 1 g
Code: 9X7O8V25IT
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT