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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078912

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GUAIFENESIN (GUAIFENESIN)
600MG
Marketing Status: Over-the-counter
Active Ingredient: GUAIFENESIN
Proprietary Name: GUAIFENESIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078912
Product Number: 001
Approval Date: Nov 23, 2011
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
GUAIFENESIN (GUAIFENESIN)
1.2GM
Marketing Status: Over-the-counter
Active Ingredient: GUAIFENESIN
Proprietary Name: GUAIFENESIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.2GM
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078912
Product Number: 002
Approval Date: Nov 5, 2020
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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