USFDA

JB Chemicals & Pharma has USFDA approval for venlafaxine hydrochloride extended release tablets. | Tech Reddy

by

[ad_1] JB Chemicals & Pharmaceuticals Ltd has received ANDA approval from USFDA for Venlafaxine Extended Release Tablets 37.5mg, 75mg, 150mg and 225mg. By design, this product is based on OROS (Osmotic Controlled Release Oral Delivery System) technology, an advanced and precisely controlled release mechanism. The generic product approval is bioequivalent and therapeutically equivalent to Osmotica … Read more

JB Chemical has received USFDA approval for Venlafaxine Extended Release tablets | Tech Reddy

by

[ad_1] JB Chemicals & Pharmaceuticals has received ANDA approval from USFDA for Venlafaxine Extended Release Tablets 37.5mg, 75mg, 150mg and 225mg. This product is based on OROS (Osmotic Controlled Release Oral Delivery System) technology, an advanced and precisely controlled release mechanism. The product generic approval is bioequivalent and therapeutically equivalent to Osmotica Pharmaceutical US LLC’s … Read more

Alembic Pharmaceuticals receives USFDA approval for Nifedipine tablets | Tech Reddy

by

[ad_1] Alembic Pharmaceuticals Limited has announced that it has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg. USFDA approved ANDA therapeutically approved by Pfizer Inc. equivalent to the company’s Procardia XL Extended-Release tablets, 30 mg, 60 mg and 90 mg. … Read more

Alembic Pharma Gets USFDA Nod for Nifedipine Extended Release Tablets | Tech Reddy

by

[ad_1] Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, according to IQVIA, the estimated market size for the twelve months ending September 2022 is USD 56 million. Alembic Pharmaceuticals Limited (Alembic) announced today that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug … Read more

Zydus receives USFDA final approval for Bisoprolol Fumarate and Hydrochlorothiazide tablets | Tech Reddy

by

[ad_1] Zydus Lifesciences has received approval from the United States Food and Drug Administration (USFDA) for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, 10 mg/6.25 mg (USRLD : Ziac tablets) received final marketing approval. The combination of bisoprolol fumarate and hydrochlorothiazide is indicated for the treatment of high blood pressure … Read more

Lupine Receives USFDA Presumptive Approval for ANDA Drospirenone Tablets | Tech Reddy

by

[ad_1] Business standard Lupine today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market the generic equivalent of Exeltis, Slind Tablets, 4 … Read more

Glenmark Pharma receives USFDA approval for sodium phenylbutyrate tablets | Tech Reddy

by

[ad_1] Glenmark Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (US FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, Generic Version Buphenyl Tablets, 500 mg, Horizon Therapeutics, LLC. According to the filings, Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, is distributed in the USA by Glenmark Pharmaceuticals Inc., USA. … Read more