Drug Approval Package: LABETALOL HYDROCHLORIDE

Company: Hikma Pharmaceuticals International Limited
Application Number: 213330
Approval Date: 11/9/2020

Drugs@FDA information available about LABETALOL HYDROCHLORIDE

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Product Quality Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Summary Review (PDF)

Date created: June 28, 2021

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