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Results For "USFDA"

1247 News Found

Zydus receives final approval from the USFDA for methylene blue injection
Drug Approval | December 07, 2023

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product


Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
Drug Approval | December 07, 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa


Zydus receives final approval from the USFDA for Ivabradine Tablets
Drug Approval | December 06, 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States


USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
News | December 02, 2023

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations


Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension
Drug Approval | December 01, 2023

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25


Lupin receives tentative approval from USFDA for Canagliflozin Tablets
Drug Approval | November 24, 2023

Lupin receives tentative approval from USFDA for Canagliflozin Tablets

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor


Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution
Drug Approval | November 24, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain


Strides receives USFDA approval for generic Suprep bowel prep kit
Drug Approval | November 23, 2023

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru


Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Drug Approval | November 22, 2023

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US