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Results For "Abbreviated-New-Drug-Application"

249 News Found

Alembic receives USFDA approval for Mesalamine ER Capsules
Drug Approval | November 03, 2022

Alembic receives USFDA approval for Mesalamine ER Capsules

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.


Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP
Drug Approval | November 01, 2022

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.


Lupin receives approval from USFDA for Darunavir Tablets
Drug Approval | October 05, 2022

Lupin receives approval from USFDA for Darunavir Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


Lupin receives US FDA approval for Mirabegron Extended-Release tablets
Drug Approval | September 30, 2022

Lupin receives US FDA approval for Mirabegron Extended-Release tablets

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US


Aptar Pharma collaborates with Fluidda
News | September 25, 2022

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms


Lupin receives approval from US FDA for Diclofenac Sodium Topical Solution USP
Drug Approval | September 23, 2022

Lupin receives approval from US FDA for Diclofenac Sodium Topical Solution USP

Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US


Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules
Drug Approval | September 08, 2022

Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules

Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings


Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets
News | August 31, 2022

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA


Lupin receives tentative approval from USFDA for Dasatinib Tablets
Drug Approval | August 29, 2022

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).