Veregen
These highlights do not include all the information needed to use VEREGEN safely and effectively. See full prescribing information for VEREGEN. Veregen (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006
Approved
Approval ID
f0fc1e21-e3cf-4bce-860c-307f670b192e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sinecatechins
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-385
Application NumberNDA021902
Product Classification
M
Marketing Category
C73594
G
Generic Name
sinecatechins
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2022
FDA Product Classification
INGREDIENTS (6)
SINECATECHINSActive
Quantity: 150 mg in 1 g
Code: T432289GYZ
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLENE GLYCOL MONOPALMITOSTEARATEInactive
Code: F76354LMGR
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT