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Abbreviated New Drug Application

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  News for Abbreviated New Drug Application

  • Business

Indian drugmakers to pay higher facility fees on US hike

The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products Drugmakers from India, the biggest source......

US to charge fee on generic drug sale application

All generic pharmaceutical companies, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories, Lupin, Glenmark and Torrent Pharma, might soon have to pay a fee to the US drug regulator when......

Cipla HIV drug gets USFDA nod

Cipla has got tentative approval from the United States Food & Drug Administration for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.According to information available on......

Lupin gets USFDA nod for Cephalexin

Lupin Ltd on Thursday said it has received USFDA approval for its Abbreviated New Drug Application for multiple strengths of antibiotic Cephalexin capsules.The approval is for Cephalexin capsules......

Zydus Cadila files 12 ANDAs in FY-04

Ahmedabad-based Zydus Cadila group has filed 12 Abbreviated New Drug Applications in fiscal 2003-04 even as the company has set a target to file 16-18 ANDAs in the current financial year.The group......

  People speak for abbreviated new drug application

  • QNA
Q. Dr Reddys lab is 1265 today risen from the low of 415 during the year----an appreciation of over 300 %. What led to this phenomenal rise of this stock? Any possible target up to March 2011?
:  A. The main reason for such a phenomenal rise is their outstanding performance both in India & overseas. The US Food & Drug Administration...... more

http://qna.rediff.com/questions-and-answers/dr-reddys-lab-is-1265-today-risen-from-the-low-of-415-during//answers/16787552

Good Citizen
Q. what is the meaning of the drug tentative approval from FDA
Good Citizen:  A. Pharma companies will be filing ANDA (Abbreviated New drug Application) to the FDA for availing approval for commercial production and marketing of...... more

http://qna.rediff.com/questions-and-answers/what-is-the-meaning-of-the-drug-tentative-approval-from-fda/16785881/answers/6661838

ravi shankar
Q. what is mean by NDA?
Ravi Shankar:  A. NDA is an abbreviation that may refer to:Non-disclosure agreement, a legal term Next-Day Air, a specification for shipping New Drug Application,...... more

http://qna.rediff.com/questions-and-answers/what-is-mean-by-nda/6661755/answers/5939713

  Web results for Abbreviated New Drug Application
New Data Shows Zohydro(R) ER Reduced Pain and Improved Function in People With Chronic Pain

Moderate and Substantial Levels of Pain Relief Produce the Greatest Functional Benefits With Zohydro(R) ER (hydrocodone bitartrate)... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=43319
Ranbaxy may lose exclusivity on Nexium generic

Ranbaxy was expected to launch its low-cost version in May, when the Nexium patent expired. Photo: Pradeep Gaur/Mint The Indian drug maker may... ...

http://www.livemint.com/Companies/LaBtqMs81oU1AhzLywYb5O/Ranbaxy-may-lose-exclusivity-on-Nexium-generic.html
Aurobindo Pharma receives USFDA approval for amoxicillin

The US Food and Drug Administration (USFDA) has granted final approval for the Hyderabad-based Aurobindo Pharma Limited to manufacture and market... ...

http://www.business-standard.com/content/b2b-pharma/aurobindo-pharma-receives-usfda-approval-for-amoxicillin-114091700443_1.html
CNPR Certification Celebrates 15 Years of Educational Success and Industry Leadership

The CNPR certificate, since its inception of the Fall of 1999, has proven to help entry level applicants understand all of the pharmaceutical... ...

http://www.bizwireexpress.com/showstoryPRWeb.php?storyid=291805
India's drug industry to touch $48 billion by 2018

Mumbai: India's drugs and pharmaceuticals industry is likely to post total sales of Rs.2.91 trillion ($47.88 billion) by 2018, with an average... ...

http://www.ibef.org/news/India-s-drug-industry-to-touch-48-billion-by-2018

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