Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA
Approval covers multiple strengths for ADHD treatment, to be manufactured at US facility
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USFDA tentative approval
USFDA gives tentative approval to Alembic Pharma’s acalabrutinib capsules, 100 mg
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, calquence capsules, 100 mg, of…
USFDA gives tentative approval to Lupin’s Dolutegravir and Rilpivirine tablets
The tablets are used to treat HIV infection
USFDA gives tentative approval to Zydus’s Levomilnacipran extended-release capsules
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad