This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis
Glenmark’s Clindamycin Phosphate Foam, 1% is bioequivalent and therapeutically equivalent to Evoclin Foam, 1%, of Mylan Pharmaceuticals.
Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis
According to IQVIATM sales data for the 12-month period ending November 2024, the Vitamin K1 Injectable Emulsion USP, 10 mg/mL market achieved annual sales of approximately $19.7 million
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
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