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Results For "reference-listed-drug"

186 News Found

Alembic receives USFDA tentative approval for fesoterodine fumarate
Drug Approval | February 02, 2022

Alembic receives USFDA tentative approval for fesoterodine fumarate

The tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency


Alembic receives USFDA approval for clarithromycin tablets
Drug Approval | February 01, 2022

Alembic receives USFDA approval for clarithromycin tablets

Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA


Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq
Drug Approval | January 28, 2022

Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq

Potassium chloride is used to prevent or to treat low blood levels of potassium


Strides receives USFDA approval for influenza medicine
Drug Approval | January 17, 2022

Strides receives USFDA approval for influenza medicine

The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval


Alembic receives tentative U.S.FDA approval for dronedarone tablets
Drug Approval | January 10, 2022

Alembic receives tentative U.S.FDA approval for dronedarone tablets

Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA


U.S. FDA grants approval for Alembic’s Parkinson’s drug
Drug Approval | January 06, 2022

U.S. FDA grants approval for Alembic’s Parkinson’s drug

Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA


Alembic receives USFDA approval for Doxycycline Hyclate
Drug Approval | January 04, 2022

Alembic receives USFDA approval for Doxycycline Hyclate

Doxycycline Hyclate Delayed Release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria


Granules receives ANDA approval for amphetamine mixed salts
Drug Approval | December 30, 2021

Granules receives ANDA approval for amphetamine mixed salts

The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health


Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin