Marksans Pharma bags USFDA nod for Acetaminophen, Ibuprofen Tablets
The pivotal approval, Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg provides relief for multiple pain-related symptoms by combining two powerful ingredients indicated for OTC pain relief, ibuprofen and acetaminophen.;
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Mumbai: Marksans Pharma Ltd., a provider of consumer self-care products, has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, over the counter ("OTC") bioequivalent of Advil Dual Action Tablets 250 mg/125 mg.
The Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) are bioequivalent to the reference listed drug (RLD), Advil Dual Action of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.
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