January 2017

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Dalfampridine Extended-Release Tablets, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Dalfampridine Extended-Release Tablets, 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Amprya® of Acorda Therapeutics, […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg to be bioequivalent

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Levalbuterol Inhalation Solution 0.31 mg/3 ml, 0.63 mg/3 ml, and 1.25 mg/3 ml. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Levalbuterol Inhalation Solution 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml to be