Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The unit has filed 2 Derma products and 1 MDI product.
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).
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
There are no data integrity (DI) observations.
With the receipt of the EIR, the inspection stands successfully closed.
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
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