The U.S. Food and Drug Administration has approved Granules India’s Abbreviated New Drug Application for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).The company said the
Granules India Limited announces approval of Acetaminophen, Aspirin and Caffeine Tablets (OTC)
Posted On: 2021-02-24 00:20:48 (Time Zone: Arizona, USA)
Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC). It is bioequivalent to the reference listed drug product (RLD), Excedrin Migraine Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at our Hyderabad facility and is expected to be launched shortly. We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine Tablets, emphasizing our focus on building sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have received three ANDA approvals over the past month. said Priyanka Chigurupati, Exec
We had mentioned in Tuesday’s closing report that Nifty, Sensex may fall further if overseas markets remain weak. On Wednesday, the indices rallied and closed with major gains. On the NSE, there were 1,227 advances, 600 declines and 411 unchanged.
Granules India announced today that the US Food & Drug Administration (US FDA) has approved its
Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250
mg/250 mg/65 mg (OTC).
It is bioequivalent to the reference listed drug product (RLD), Excedrin Migraine
Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be
manufactured at the company s Hyderabad facility and is expected to be launched shortly.
Acetaminophen, Aspirin and Caffeine Tablets are indicated for the treatment of migraine.
Granules now has a total of 38 ANDA approvals from US FDA (37 Final approvals and 1 tentative
approval)
Powered by Capital Market - Live News
someone would have to make an effort to consume 40 or so 200-mg caffeine tablets. or. about this much 5-hour energy. in a single day. we recommend. not more than two per day. yeah, when we first came out with the product. you know, i made sure of one thing. if my family wasn t going to use it. if it wasn t good enough for my family if it wasn t safe for my family. i m not gonna put it out there. i take it almost every day. and twice when i play tennis. this is our criteria that we have to be safe. if we re not willing to do it ourselves. we re not asking anybody else to do it. we re not gonna sell it. so, that s our approach to safety. that is a higher standard you can get. eric: house republicans