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)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual ... in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon ... fun run is geared towards children of all ages; it is a non-competitive, non-timed ...
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
(Date:10/12/2017)... New Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... fitness centers in the U.S., announced today its plans to open a flagship location ... club will occupy the former Rooms To Go store next to Office Depot in ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
(Date:10/12/2017)... ... , ... Leading pediatric oncology experts at Children’s National Health System ... of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by ... Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of the ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... to the Centers for Disease Control and Prevention (CDC), influenza vaccination ... is helping communities across Massachusetts , Connecticut ... flu shots through the end of the month. *Some exclusions ... ... shot is by the end of October, according to the Centers for ...
(Date:10/2/2017)... Mich. , Oct. 2, 2017 Diplomat ... 8th Day Software and Consulting, LLC , and ... 8th Day Software, based in Tennessee ... LLC. 8th Day expands EnvoyHealth,s service offerings for health ... development. "In an ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
Breaking Medicine Technology: