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

395 News Found

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


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


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


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


Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
News | September 08, 2023

Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma

Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated


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


Lupin receives USFDA approval for Pirfenidone Capsules
Drug Approval | August 31, 2023

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US


Unichem receives ANDA approval for Prasugrel Tablets
Drug Approval | August 31, 2023

Unichem receives ANDA approval for Prasugrel Tablets

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events