← FDA Drug Approvals (Drugs@FDA)
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
NDA · New Drug Application · Sponsor: RB HLTH · Approved 2025-12-22
Drug application
- FDA Application #
NDA217338- Application type
- New Drug Application
- Brand name
- MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
- Generic name
- Dextromethorphan Hydrobromide
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- RB HLTH
- First approval
- 2025-12-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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