Alembic Pharma announces US FDA tentative approval for Ivosidenib tablets 250 mg
The approved ANDA is therapeutically equivalent to the RLD product, Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals
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Browsing Tag
US Food & Drug Administration
Alembic Pharma gets tentative US FDA nod for generic Rivaroxaban tablets
The tablet is the generic of Janssen Pharmaceuticals's reference listed drug product Xarelto
Granules India arm gets USFDA nod for Valganciclovir hydrochloride oral solution
Valganciclovir hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections Granules India said…
Aurobindo Pharma receives US FDA approval for Omeprazole delayed-release capsules
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults
US FDA issues warning letter to Mylan
Inspectors found 'significant violations' in the three manufacturing facilities in Bengaluru The US Food & Drug…
Aurobindo Pharma receives US FDA approval for Esmolol Hydrochloride injection
Esmolol Hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during…
Aurobindo Pharma receives US FDA approval for Cefixime for oral suspension USP
Cefixime for oral suspension is indicated for the treatment of adults and paediatric patients six months of age or older