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Results For "USP"

382 News Found

Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US
Drug Approval | March 07, 2025

Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US

Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals


Glenmark Pharmaceuticals USA launches Epinephrine Injection USP
News | February 27, 2025

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP

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.


NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension
Drug Approval | February 10, 2025

NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension

TFOS is indicated for the treatment of pulmonary arterial hypertension


NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension
Drug Approval | January 31, 2025

NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma


Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP
News | January 22, 2025

Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP

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


Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval | January 13, 2025

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

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


Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP
Drug Approval | December 20, 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)


Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension
Drug Approval | December 09, 2024

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen


Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%
News | November 28, 2024

Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%

Glenmark's Travoprost Ophthalmic Solution USP, 0.004% is bioequivalent and therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution USP, 0.004% of Sandoz


Lupin launches Bumetanide Injection USP in US
News | November 20, 2024

Lupin launches Bumetanide Injection USP in US

Bumetanide Injection USP (RLD Bumex) had an estimated annual sale of USD 20 million in the US