Alembic Pharma gets USFDA nod for generic version of Macrodantin Capsules
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Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, has recently announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), 'Macrodantin Capsules, 25 mg, 50 mg, and 100 mg, of Alvogen Malta Operations Ltd.
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