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Results For "USFDA"

1134 News Found

Strides receives USFDA approval for Icosapent Ethyl Capsules
Drug Approval | September 25, 2023

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)


Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%
Drug Approval | September 21, 2023

Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%

Clindamycin Phosphate Gel is used to treat acne


USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA
Drug Approval | September 21, 2023

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483


Strides receives tentative USFDA approval for Dolutegravir/Lamivudine/Tenofovir Disproxil Fumurate tablets
Drug Approval | September 16, 2023

Strides receives tentative USFDA approval for Dolutegravir/Lamivudine/Tenofovir Disproxil Fumurate tablets

Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa


Zydus receives final approval from USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System
Drug Approval | September 16, 2023

Zydus receives final approval from USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States


Strides receives tentative USFDA approval for Dolutegravir tablets
Drug Approval | September 15, 2023

Strides receives tentative USFDA approval for Dolutegravir tablets

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


Bajaj Healthcare announces receipt of EIR from USFDA
Drug Approval | September 14, 2023

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations


Strides receives USFDA approval for Sevelamer Carbonate for oral suspension
Drug Approval | September 11, 2023

Strides receives USFDA approval for Sevelamer Carbonate for oral suspension

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


Zydus receives final USFDA approval for Erythromycin Tablets
Drug Approval | September 03, 2023

Zydus receives final USFDA approval for Erythromycin Tablets

Erythromycin tablets is used to prevent and treat infections in many different parts of the body