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Results For "tentative-approval"

257 News Found

Eugia Pharma receives USFDA approval for Triamcinolone Acetonide Injectable Suspension
Drug Approval | July 07, 2022

Eugia Pharma receives USFDA approval for Triamcinolone Acetonide Injectable Suspension

This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.


Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection
Drug Approval | June 08, 2022

Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection

he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.


Eugia Pharma receives USFDA approval for Pemetrexed
Drug Approval | May 26, 2022

Eugia Pharma receives USFDA approval for Pemetrexed

Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)


Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets
Drug Approval | May 24, 2022

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA


Alembic Pharmaceuticals receives USFDA  approval for Arformoterol Tartrate
Drug Approval | May 11, 2022

Alembic Pharmaceuticals receives USFDA approval for Arformoterol Tartrate

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate
Drug Approval | May 09, 2022

Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate

Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA


Eugia Pharma receives USFDA approval for Bortezomib
Drug Approval | May 04, 2022

Eugia Pharma receives USFDA approval for Bortezomib

The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA


Aleor Dermaceuticals receives USFDA approval for Docosanol Cream
Drug Approval | May 04, 2022

Aleor Dermaceuticals receives USFDA approval for Docosanol Cream

Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA


Aleor Dermaceuticals receives USFDA approval for Clobestasol
Drug Approval | April 25, 2022

Aleor Dermaceuticals receives USFDA approval for Clobestasol

Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA


Aleor receives USFDA approval for Lidocaine and Prilocaine Cream
Drug Approval | April 12, 2022

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA