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).
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
The US business faced price erosion due to increased competition.
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets
Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA
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