Granules India receives ANDA approval for Glycopyrrolate Oral Solution
It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz Pharmaceuticals
Granules India announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL filed by Granules Pharmaceuticals, a wholly owned foreign subsidiary of the Company.
It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz Pharmaceuticals
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients aged three to 16 years who have neurological conditions associated with problem drooling.
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