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Results For "ANDA-approval"

201 News Found

Glenmark receives ANDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Glenmark receives ANDA approval for Lacosamide tablets

The company plans to launch the product immediately


Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug
Drug Approval | March 19, 2022

Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug

The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis


Unichem receives ANDA approval for hypertension drug
Drug Approval | March 16, 2022

Unichem receives ANDA approval for hypertension drug

Nebivolol is used alone or together with other medicines to treat high blood pressure


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches


Granules receives ANDA approval for anti-depressant medication
Drug Approval | February 03, 2022

Granules receives ANDA approval for anti-depressant medication

It has a total of 50 ANDA approvals from USFDA


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


Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%
Drug Approval | January 28, 2022

Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%

Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA


Glenmark receives ANDA approval for hydrochlorothiazide tablets
Drug Approval | January 27, 2022

Glenmark receives ANDA approval for hydrochlorothiazide tablets

According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million


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