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"abbreviated-new-drug-application"

  • Granules India Limited receives final approval from USFDA for its new drug

    Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as for Moderate to Severe Binge Eating Disorder (BED) in adults
  • Granules receives nod for potassium chloride for oral solution

    Hyderabad: Granules India said on Friday that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India, for Potassium Chloride for Oral Solution USP, 20 mEq. Potassium chloride is used to prevent or to treat low […]

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