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:10/13/2017)... ... 2017 , ... Coveros, a leader in agile coaching services ... by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile Transformation ... Agile methodologies in a consistent and high value manner across CMS programs. Coveros ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... to meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s ... experts and tested to meet the highest standard. , These products are ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical ... Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. ... honor of Morris F. Collen, a pioneer in the field of medical informatics, this ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... The Rebound mobile app is poised to become a vital ... prescription drug addiction. The app empowers users to develop an ... their dosage in a safe, controlled manner while maximizing well-being. ... 100,000 people to sign up will enjoy 3 months of ... ...
(Date:9/27/2017)... their devotion to personalized service, SMP Pharmacy Solutions announces their ... South Florida Business Journal,s 50 Fastest-Growing Companies, and listed for ... specialty pharmacy has found its niche.  To that end, the ... by SFBJ as the 2017 Power Leader in Health Care. ... award in October, Bardisa said of the three achievements, "It,s ...
(Date:9/25/2017)... PROVIDENCE, R.I. , Sept. 25, 2017 /PRNewswire/ ... immunogenicity assessment, vaccine design, and immune-engineering today announced ... focused on the development of personalized therapeutic cancer ... and has provided exclusive access to enabling technologies ... MSc Eng., MBA will lead EpiVax Oncology as ...
Breaking Medicine Technology: