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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

2c1cd745-79ab-487d-b759-995794cedb92

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 12, 2021

Manufacturers
FDA

PharmaDerm a division of Fougera Pharmaceuticals Inc.

DUNS: 043838424

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 Code10337-450
Application NumberNDA021902
Product Classification
M
Marketing Category
C73594
G
Generic Name
sinecatechins
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2021
FDA Product Classification

INGREDIENTS (1)

SINECATECHINSActive
Quantity: 150 mg in 1 g
Code: T432289GYZ
Classification: ACTIB

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Veregen - FDA Drug Approval Details