Licensed vaccine

BCG Vaccine

FDA-licensed vaccine · Organon Teknika Corp., LLC · STN 103050

Key facts

Trade name BCG Vaccine
Proper name BCG Live
Manufacturer Organon Teknika Corp., LLC
Submission tracking number (STN) 103050
Recent FDA documents Instructions for Using BCG Vaccine, Package Insert - BCG Vaccine, Supporting Documents older than three years - BCG Vaccine
FDA page updated Feb 21, 2018
FDA product page fda.gov

At a glance

  • None 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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