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
Potassium chloride is used to prevent or to treat low blood levels of potassium
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA
Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA
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
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
The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health
The capsules are the generic version of the reference listed drug Mycobutin
The tablets are indicated for the treatment of pulmonary arterial hypertension
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
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