Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021282

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MUCINEX (GUAIFENESIN)
600MG Marketing Status: Over-the-counter

Active Ingredient: GUAIFENESIN
Proprietary Name: MUCINEX
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021282
Product Number: 001
Approval Date: Jul 12, 2002
Applicant Holder Full Name: RB HEALTH US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

MUCINEX (GUAIFENESIN)
1.2GM Marketing Status: Over-the-counter

Active Ingredient: GUAIFENESIN
Proprietary Name: MUCINEX
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.2GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021282
Product Number: 002
Approval Date: Dec 18, 2002
Applicant Holder Full Name: RB HEALTH US LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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