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).
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
The product will be manufactured at Lupin's facility in Goa, India.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions
The product will be manufactured at Lupin’s facility in Goa, India.
The product will be manufactured at Lupin's facility in Nagpur, India.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
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