Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091071

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GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE)
600MG;60MG
Marketing Status: Over-the-counter

Active Ingredient: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG;60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091071
Product Number: 001
Approval Date: May 27, 2015
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE)
1.2GM;120MG
Marketing Status: Over-the-counter

Active Ingredient: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.2GM;120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091071
Product Number: 002
Approval Date: May 27, 2015
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information