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Results For "tentative-approval"

257 News Found

Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray
Drug Approval | March 20, 2024

Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray

The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024


Biocon Biologics secures Canada market entry date for YESAFILI
News | March 05, 2024

Biocon Biologics secures Canada market entry date for YESAFILI

This agreement paves the way for the introduction of YESAFILI into the Canadian market


Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg
Drug Approval | March 02, 2024

Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg

The product will be launched in March 2024


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection
Drug Approval | December 27, 2023

Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection

The product is expected to be launched in December 2023


Lupin receives tentative USFDA approval for Sitagliptin Tablets
Drug Approval | December 18, 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus


Zydus receives final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg
News | December 17, 2023

Zydus receives final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg

Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body


Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets
Drug Approval | December 14, 2023

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD


Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
Drug Approval | December 07, 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa