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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021620

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MUCINEX DM (DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN)
30MG;600MG
Marketing Status: Over-the-counter
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Proprietary Name: MUCINEX DM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG;600MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021620
Product Number: 002
Approval Date: Apr 29, 2004
Applicant Holder Full Name: RB HEALTH US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
MUCINEX DM (DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN)
60MG;1.2GM
Marketing Status: Over-the-counter
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Proprietary Name: MUCINEX DM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG;1.2GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021620
Product Number: 001
Approval Date: Apr 29, 2004
Applicant Holder Full Name: RB HEALTH US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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