tentative

Alembic Pharma receives USFDA’s tentative approval for Alogliptin Tablet

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Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and 25mg of Takeda Pharms USA. … Read more

Lupin receives tentative approval from USFDA for generic Lurasidone Hydrochloride Tablets

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Lupin has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. Lupin’s Lurasidone … Read more

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