Alembic Pharma receives US FDA tentative approval for Dasatinib tablets
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Sprycel tablets, 20 mg, 50…
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US FDA tentative approval
Zydus receives tentative approval from US FDA for Selexipag tablets
Selexipag is used in adults to treat Pulmonary Arterial Hypertension (PAH) to delay disease progression and reduce the risk of…
Alembic Pharma announces US FDA tentative approval for Dabigatran Etexilate capsules
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Pradaxa capsules, 75 mg,…