Issued to RB Health (US) LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 26, 2024Application
NDA 505b1 • 217338
Product
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
Company
RB Health (US) LLC
Review center
CDERStage
Final Decision
Response due
July 26, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to RB Health (US) LLC on July 26, 2024.
NDA 217338 is the application under which FDA issued this complete response letter for MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM to RB Health (US) LLC. It was reviewed by FDA CDER. The letter is dated July 26, 2024.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.