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Results For "United-States-Food-and-Drug-Administration"

403 News Found

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


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


Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP
Drug Approval | August 11, 2025

Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP

Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle


Zydus receives final approval from USFDA for Prucalopride Tablets
Drug Approval | August 09, 2025

Zydus receives final approval from USFDA for Prucalopride Tablets

Prucalopride is prescribed for chronic idiopathic constipation


Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products
Drug Approval | July 24, 2025

Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products

Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India


Zydus receives tentative approval from USFDA for Ibrutinib tablets
Drug Approval | July 24, 2025

Zydus receives tentative approval from USFDA for Ibrutinib tablets

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad


Zydus receives final approval from USFDA for Celecoxib Capsules
Drug Approval | July 15, 2025

Zydus receives final approval from USFDA for Celecoxib Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug


Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Drug Approval | July 02, 2025

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery