Navigation Links
Amneal Receives FDA Approval for Bethanechol Chloride Tablets, USP Using New Expedited FDA Approval Process
Date:11/29/2007

PATERSON, N.J., Nov. 29 /PRNewswire/ -- Amneal Pharmaceuticals is pleased to announce that it received US FDA approval to manufacture Bethanechol Chloride Tablets, USP in strengths of 5mg, 10mg, 25mg and 50 mg, effective November 21, 2007. Bethanechol HCl is an AA-Rated, therapeutically equivalent alternative to Urecholine(R) (a trademark of Barr Laboratories).

The Bethanechol approval represents a breakthrough for Amneal, who is one of the very first companies to submit an ANDA in the FDA's new, optional eCTD/QBR/QOS format. This application method resulted in a significantly more efficient approval evaluation process, dramatically reducing anticipated approval time. Amneal's Bethanechol eCTD application was approved just 10 months and 10 days after its January 2007 application date. All of Amneal's ANDAs since Bethanechol are being filed using the eCTD format.

Amneal will begin shipping Bethanechol in the 25mg strength as of January 4, 2008 with the other three strengths beginning in February 2008. Amneal's Bethanechol is expected to be available through wholesalers-distributors as well as directly to customers.

Amneal Pharmaceuticals LLC, headquartered in Paterson, NJ, is a USA-based firm that develops, manufacturers and distributes generic pharmaceutical products regulated and approved by the US FDA. Positioned as "Generic's New Generation," the company utilizes diverse R&D and manufacturing expertise to conceive breakthrough developments with lasting impact. Vigorous ANDA growth and broad product acquisitions are key features of Amneal's strategic growth plan, as is the company's commitment to building deep relationships with its customer base. Amneal delivers superior service levels, quality products, and dynamic value throughout the pharmaceutical industry.


'/>"/>
SOURCE Amneal Pharmaceuticals LLC
Copyright©2007 PR Newswire.
All rights reserved

Page: 1

Related medicine news :

1. Amneal Pharmaceuticals & Indoco Remedies Finalize Long Term Joint Venture Agreement to Develop and Market Generic Ophthalmic Pharmaceuticals
2. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
3. DaVita Receives Civil Complaint
4. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
5. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
6. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
7. Mayo Clinic Multidisciplinary Simulation Center Receives Distinction as an ACS-Accredited Education Institute
8. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
9. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
10. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
11. Prime Therapeutics Receives TIPPS Certification
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... ... June 23, 2017 , ... ... personal financial planning to families and business owners in North Central West Virginia, ... help provide services to differently abled residents in the region. , The Stepping ...
(Date:6/22/2017)... , ... June 22, 2017 , ... Plastic Surgery Associates ... a Top Doctor for 2017. Each year, research and information firm, Castle Connolly, releases ... the title in 2015, this marks the 3rd time that Dr. Canales ...
(Date:6/22/2017)... Washington, DC (PRWEB) , ... June 22, 2017 ... ... awarded a $3.7 million grant from the American Heart Association (AHA) to launch ... economic incentives to improve the prevention and diagnosis of rheumatic heart disease (RHD) ...
(Date:6/22/2017)... ... 22, 2017 , ... Vighter, a premier provider of Unconventional ... ANSI/ASIS PSC.1-2012. The company’s work in countries throughout Southwest Asia, South America, and ... been degraded. The PSC.1 standard was created to protect fundamental freedoms and human ...
(Date:6/20/2017)... ... June 20, 2017 , ... TwelveStone Health Partners, a ... Nashville-based private equity firm, has invested $3.35 million in the company. , ... Claritas Capital offers the smart money, speed to market and accountability we had ...
Breaking Medicine News(10 mins):
(Date:6/10/2017)... Ala. , June 9, 2017  Shane K. Burchfield, DPM, ... recognized for excellence as a Podiatrist in Alabama ... Podiatry at Family First Foot Care. He brings over 20 years ... medicine, pain management and healthcare, to his role. ... First Foot Care, PC is pleased to welcome you ...
(Date:6/8/2017)... June 8, 2017  Less than a month ago, ... than 200,000 companies, including hospital networks, in over 150 ... one of the largest online extortion attempts ever recorded. ... market, it is imperative that providers understand where the ... from this — and many other very real cyber ...
(Date:6/7/2017)... June 7, 2017 Endo International plc (NASDAQ: ... 2017, the Hon. Joseph R. Goodwin , U.S. ... West Virginia , entered a case management ... Repair System Products Liability Litigation (the "MDL") that includes ... to provide expert disclosures on specific causation within one ...
Breaking Medicine Technology: