Drug Approval | September 01, 2022
Zydus receives final approval from USFDA for two tablets
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
The unit has filed 2 Derma products and 1 MDI product.
There are no data integrity (DI) observations.
Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
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.
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