March 28, 2017
Aurobindo Pharma Ltd.’s ANDA 205835 for Meropenem for Injection was approved on 27 Mar. 2017 by US FDA.
AuroMedics, a subsidiary of Aurobindo, will commence marketing the product in April 2017.
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March 22, 2017
Aurobindo received FDA approval for Guaifenesin and Dextromethorphan Hydrobromide Extended-Release Tablets (OTC), 600/30 mg and 1200/60 mg.
February 27, 2017
GPhA changes name to the Association for Accessible Medicines
Its new identity will improve recognition that the generic and biosimilar medicines industry is one of “the nation’s great health care success stories, and that competition from generics and biosimilars lowers the cost of medicine.” WASHINGTON — The Generic Pharmaceutical Association on Tuesday unveiled a new national effort to contain the cost of prescription medicines. […]
January 25, 2017
Aurobindo Receives FDA Approval for Dalfampridine Extended-Release Tablets, 10 mg
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, […]
January 20, 2017
Aurobindo Receives FDA Approval for Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg
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 […]
January 18, 2017
Aurobindo Receives FDA Approval for Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg
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 […]
January 06, 2017
Aurobindo Receives FDA Approval for Levalbuterol Inhalation Solution 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml
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 […]
July 18, 2016
Aurobindo receives final FDA Approval for Hydrocodone Bitartrate and Ibuprofen Tablets (C-II)
Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II). The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II), to be bioequivalent and, therefore, therapeutically equivalent to the reference […]