The product is bioequivalent and therapeutically equivalent to Fresenius Kabi’s reference drug (NDA 212832)
Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension
According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The product will be marketed by Dr. Reddy's Laboratories Inc.
Sumatriptan injection is indicated in adults for the acute treatment of migraine
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