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FDA Approval

GENOSYL

CompanyVERO BIOTECH, INC. (DUNS: 872672477)

Effective Date

December 19, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nitric Oxide(0.98 mg in 1 L)

Registrants (1)

VERO BIOTECH LLC

DUNS Number

872672477

Manufacturing Establishments (1)

VERO BIOTECH, INC.

Labeler

VERO BIOTECH, INC.

Registrant

VERO BIOTECH LLC

DUNS Number

872672477

Products (1)

GENOSYL

NDC Product Code

72385-001

Application Number

NDA202860

Marketing Category

NDA (C73594)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

December 19, 2023

Ingredients

Nitric OxideActive

Code: 31C4KY9ESHClass: ACTIBQuantity: 0.98 mg in 1 L

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