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Results For "reference-listed-drug"

196 News Found

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure


Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection
News | September 02, 2025

Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection

Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai


Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited


Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial
News | August 19, 2025

Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial

According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million


Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
News | August 19, 2025

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension


Indoco Remedies receives final USFDA approval for rivaroxaban tablets
Drug Approval | August 13, 2025

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Rivaroxaban is used to treat venous thromboembolism


Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags
Drug Approval | August 12, 2025

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA


Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP
Drug Approval | July 27, 2025

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug