The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
The approved ANDA is therapeutically equivalent to the reference listed drug product
Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025
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