Product Information

• Package Insert - DAPTACEL (PDF - 217KB)

Supporting Documents

• July 27, 2012 Approval Letter - DAPTACEL
  To include safety information regarding the risk of apnea in premature infants to the Warnings and Precautions section of the package insert.
• July 19, 2012 Summary Basis for Regulatory Action-DAPTACEL (PDF - 58KB)
• July 15, 2011 Approval Letter - DAPTACEL
  To include changes to the package insert to update the safety data on use of a fifth dose of DAPTACEL® in children four through six years of age who received four doses of PENTACEL®.
• July 12, 2011 Summary Basis for Regulatory Action - DAPTACEL (PDF - 48KB)
• March 12, 2008 Approval Letter - DAPTACEL
  To include a fifth dose booster immunization at 4 to 6 years of age following four previous doses of DAPTACEL.
• Committee Chair Approval Memo - DAPTACEL
• Clinical Review - DAPTACEL (PDF - 178KB)
• May 14, 2002 Approval Letter - DAPTACEL
  Active immunization of infants and toddlers at 2, 4, 6, and 17-20 months of age against diphtheria, tetanus and pertussis.
• Clinical Review - DAPTACEL  (PDF - 464KB)

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