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Results For "FDA"

1712 News Found

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets
Drug Approval | October 05, 2023

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products


Alembic received 6 USFDA approvals during Q2FY24
Drug Approval | October 05, 2023

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets


Strides receives USFDA approval for Icosapent Ethyl capsules
Drug Approval | October 04, 2023

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin


SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance
Startup | October 03, 2023

SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana
Drug Approval | September 29, 2023

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics


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