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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021585

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MUCINEX D (GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE)
600MG;60MG
Marketing Status: Over-the-counter
Active Ingredient: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: MUCINEX D
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG;60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021585
Product Number: 001
Approval Date: Jun 22, 2004
Applicant Holder Full Name: RB HEALTH US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
MUCINEX D (GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE)
1.2GM;120MG
Marketing Status: Over-the-counter
Active Ingredient: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: MUCINEX D
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.2GM;120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021585
Product Number: 002
Approval Date: Jun 22, 2004
Applicant Holder Full Name: RB HEALTH US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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