Enforcement Report - Week of January 10, 2024
Marksans Pharma, one of the fastest-growing pharmaceutical companies in India, has announced that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC). The Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC) are bioequivalent to the reference listed drug (RLD), Mucinex Extended-Release Tablets, 600 mg and 1200 mg, of RB Health (US) LLC.
Marksans's Generic Guaifenesin Receives Approval in the U.S.
Dr. Reddy's Lab Generic Dextromethorphan Hydrobromide Receives Approval in US
Enforcement Report - Week of June 7, 2023
Ferring and BioInnovation Institute enter new strategic collaboration to accelerate innovation in women’s health
Enforcement Report - Week of February 9, 2022
L Perrigo's Generic Guaifenesin & Pseudoephedrine HCl Receives approval in U.S.
Enforcement Report - Week of January 26, 2022
Sun Pharm`s Generic Guaifenesin; Dextromethorphan HBr Receives Approval In US