USFDA nod to Marksans Pharma Famotidine Tablets for OTC use
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Mumbai: Marksans Pharma Limited has announced that the company has received final approval from US Food & Drugs Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use.
The product is bioequivalent to the reference listed drug (RLD), Pepcid AC tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $ 200 million in the US market.
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