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FDA Approval

Veregen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 10, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sinecatechins(150 mg in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Veregen

Product Details

NDC Product Code
62559-385
Application Number
NDA021902
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
January 1, 2022
Code: T432289GYZClass: ACTIBQuantity: 150 mg in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
PROPYLENE GLYCOL MONOPALMITOSTEARATEInactive
Code: F76354LMGRClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
WHITE WAXInactive
Code: 7G1J5DA97FClass: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DVClass: IACT
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