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: A209692
Product Number: 001
Approval Date: Nov 1, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:
Over-the-counter
Patent and Exclusivity Information
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: A209692
Product Number: 002
Approval Date: Nov 1, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:
Over-the-counter
Patent and Exclusivity Information