Drug Approval Package: Lamivudine, Nevirapine and Zidovudine

Company: Micro Labs USA Inc.
Application Number: 205626
Approval Date: 08/13/2018

Drugs@FDA information available about Lamivudine

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Other Action Letters (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)

Date created: November 26, 2018

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