Licensed vaccine

Influenza A (H1N1) 2009 Monovalent Vaccine

FDA-licensed vaccine · Novartis Vaccines and Diagnostics Limited · STN 103837

Key facts

Proper name Influenza A (H1N1) 2009 Monovalent Vaccine
Manufacturer Novartis Vaccines and Diagnostics Limited
Submission tracking number (STN) 103837
Recent FDA documents Package Insert - Influenza A (H1N1) 2009 Monovalent (Novartis Vaccines and Diagnostics Limited), September 15, 1009 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited)
FDA page updated Mar 22, 2018
FDA product page fda.gov

At a glance

  • 1–9 FDA approval letters
  • 1–9 Supporting documents
  • 1–9 Product information documents
  • Yes Document full text searchable in Orca1

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-licensed vaccines

The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.

Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date:

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