Lupin receives USFDA approval for Tolvaptan Tablets
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
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