Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 207602

Expand all

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN)
30MG;600MG
Marketing Status: Over-the-counter

Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Proprietary Name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG;600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A207602
Product Number: 002
Approval Date: Mar 5, 2018
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN)
60MG;1.2GM
Marketing Status: Over-the-counter

Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Proprietary Name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG;1.2GM
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A207602
Product Number: 001
Approval Date: Mar 5, 2018
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information