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).
Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
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.
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
The product will be manufactured at Lupin’s facility in Goa, India.
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
The product will be manufactured at Lupin's facility in Nagpur, India.
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