he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The product will be manufactured at Lupin's facility in Goa, India.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
The product will be manufactured at Lupin’s facility in Goa, India.
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
63-year old woman gets rare Transcatheter Tricuspid Valve Replacement (TTVR)
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
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