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

417 News Found

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection
Drug Approval | April 17, 2023

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output


Zydus receives final approval from USFDA for Tavaborole Topical Solution
Drug Approval | April 12, 2023

Zydus receives final approval from USFDA for Tavaborole Topical Solution

Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States


Zydus receives final approval from the USFDA for Azithromycin Tablets
Drug Approval | April 11, 2023

Zydus receives final approval from the USFDA for Azithromycin Tablets

Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States


Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms


Zydus receives final approval from the USFDA for Acetazolamide Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Acetazolamide Tablets

Acetazolamide is used to treat glaucoma


Zydus receives final approval from USFDA for Loperamide Hydrochloride Capsules
Drug Approval | March 29, 2023

Zydus receives final approval from USFDA for Loperamide Hydrochloride Capsules

Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States


Lupin receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | March 28, 2023

Lupin receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).


Briefs: Morepen Laboratories and Zydus Lifesciences
Drug Approval | March 27, 2023

Briefs: Morepen Laboratories and Zydus Lifesciences

The company is addressing these observations


Lupin announces completion of pharmacovigilance inspection by USFDA
Drug Approval | March 27, 2023

Lupin announces completion of pharmacovigilance inspection by USFDA

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide


Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg
Drug Approval | March 25, 2023

Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg

Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety