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FDA Approval

NIACINAMIDE 4% / TRETINOIN 0.05%

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

FDA Approval Summary

Company
Sincerus Florida, LLC
DUNS: 080105003
Effective Date
May 3, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nicotinamide(4 g in 100 g)
Tretinoin(0.05 g in 100 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Sincerus Florida, LLC

Sincerus Florida, LLC

080105003

Products1

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

NIACINAMIDE 4% / TRETINOIN 0.05%

Product Details

NDC Product Code
72934-1164
Route of Administration
TOPICAL
Effective Date
May 3, 2019
Code: 25X51I8RD4Class: ACTIBQuantity: 4 g in 100 g
TretinoinActive
Code: 5688UTC01RClass: ACTIBQuantity: 0.05 g in 100 g
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