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Results For "Abbreviated-New-Drug-Application"

233 News Found

Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation
News | August 16, 2022

Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation

ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions


Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP
Drug Approval | August 13, 2022

Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP

The product will be manufactured at Lupin’s facility in Goa, India.


Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
Drug Approval | July 26, 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

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


Lupin receives approval from USFDA for Paliperidone extended-release tablets
Drug Approval | July 01, 2022

Lupin receives approval from USFDA for Paliperidone extended-release tablets

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S


Glenmark Pharmaceuticals expand its OTC portfolio
News | June 29, 2022

Glenmark Pharmaceuticals expand its OTC portfolio

The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world


ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP
Drug Approval | June 24, 2022

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.


Alembic receives USFDA tentative approval for Dasatinib tablets
Drug Approval | June 12, 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive


Lupin receives tentative approval from FDA for Ivacaftor tablets
Drug Approval | June 08, 2022

Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.


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