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Results For "bioequivalent"

158 News Found

Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


Glenmark launches Tavulus for COPD treatment in Spain
Drug Approval | October 11, 2021

Glenmark launches Tavulus for COPD treatment in Spain

It is one of the first companies to launch a bioequivalent version of the dry powder inhaler and it's part of the company’s strategic exclusive in-licensing arrangement to market Tiotropium DPI in Western Europe and the UK


Gland Pharma receives tentative nod for Sugammadex injection
Drug Approval | October 09, 2021

Gland Pharma receives tentative nod for Sugammadex injection

The injection is used to reverse the effects of the muscle relaxants given to patients during surgery


Granules India receives approval from Health Canada for arthritis drug
News | August 30, 2021

Granules India receives approval from Health Canada for arthritis drug

Acetaminophen extended-release tablets 650 mg is bioequivalent of the reference listed drug Tylenol


Marksans announces US FDA approval for Acetaminophen Extended- Release tablets
News | August 27, 2021

Marksans announces US FDA approval for Acetaminophen Extended- Release tablets

The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India


Glenmark receives ANDA approval for theophylline extended-release tablets
News | June 07, 2021

Glenmark receives ANDA approval for theophylline extended-release tablets

Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets


Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.


Granules India announces approval of Potassium Chloride ER Capsules
News | February 18, 2021

Granules India announces approval of Potassium Chloride ER Capsules

Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).