Abbreviated New Drug Applications

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Aurobindo Pharma on Wednesday said its tentatively approved abbreviated new drug applications for Nevirapine Tablets 200mg and Nevirapine oral suspension have received final approval from US Food and Drug Administration (FDA). Aurobindo's ...
May 23, 2012 at 08:06 | Source: MoneyControl.com
The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDAs), new drug applications (NDAs) and 505(b)(2) NDA products. Areas of interest include products that could ...
May 25, 2012 at 14:23 | Source: Business Wire
As of May 23, 2012, the company had 173 abbreviated new drug applications (ANDAs) pending clearance by the FDA, targeting $92 billion in sales annually. Mylan believes that about 38 of these ANDAs are first-to-file opportunities, representing approximately ...
May 24, 2012 at 21:41 | Source: NASDAQ
As of May 23, 2012, the company had 173 abbreviated new drug applications (ANDAs) pending clearance by the FDA, targeting $92 billion in sales annually. Mylan believes that about 38 of these ANDAs are first-to-file opportunities, representing ...
May 25, 2012 at 17:01 | Source: Yahoo Finance
As of May 23, 2012, the company had 173 abbreviated new drug applications (ANDAs) pending clearance by the FDA, targeting $92 billion in sales annually. Mylan believes that about 38 of these ANDAs are first-to-file opportunities, representing ...
May 24, 2012 at 21:05 | Source: Yahoo Finance
This year is a busy year and there are quite a few launches." The company owns 80 abbreviated new drug applications that are yet to receive approval by the US Food and Drug Administration (FDA) and about seven has about 80 abbreviated new drug applications ...
May 14, 2012 at 07:20 | Source: Top News India
During the year, Dr. Reddy’s launched 16 new generic products, filed 17 abbreviated new drug applications (ANDAs) with the U.S. Food and Drug Administration (FDA). Cumulatively 80 ANDAs are pending for approval with the FDA, of which 41 are ...
May 14, 2012 at 12:56 | Source: Boston Globe
The company''s current portfolio consists of 80 products authorised for distribution in the US and 38 abbreviated new drug applications (ANDA''s) pending approval with the USFDA, it added. Shares of Glenmark Pharmaceuticals were today trading at Rs 355 in ...
May 16, 2012 at 12:32 | Source: MSN India
In 2011-12, it sought the USFDA’s approvals for 17 generic drugs. Dr Reddy’s has 80 abbreviated new drug applications pending with the USFDA for approval. Of these, seven have first-to-file status, which will enable the company to exclusively market ...
May 16, 2012 at 18:59 | Source: Business Standard
Ranbaxy Laboratories Inc. Janssen alleges the generics makers filed abbreviated new drug applications with the U.S. Food and Drug Administration to produce and sell versions of... To view the full article, take a free trial now.
May 23, 2012 at 17:10 | Source: site.law360.com