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Abbreviated New Drug Application

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FDA hikes fee for drug approvals, cuts unit inspection charge

US regulator FDA has hiked its fees for new generic drug applications by up to 30 per cent, a move that may hit hard Indian drugmakers, which account for a major chunk of generic medicines sold in......

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......
  Web results for Abbreviated New Drug Application
Taro Provides Results for December 31, 2015

Taro Pharmaceutical Industries Ltd. (NYSE:TARO) (Taro or the Company) provided unaudited financial results for the three and nine months ended... ...

http://businesswireindia.com/news/news-details/taro-provides-results-december-31-2015/47310
Shilpa Medicare gets USFDA approval for API plants in Karnataka

The inspection by the US Food and Drug Administration for Shilpa Medicare to sell active pharmaceutical ingredients took place in November... ...

http://www.livemint.com/Companies/TdZGlDHr1kZFJfcFwBXO1I/Shilpa-Medicare-gets-USFDA-approval-for-API-plants-in-Karnat.html
Lannett Receives FDA Approval For Temozolomide Capsules

Lannett CO (NYSE:LCI) Intraday Stock Chart Today : Thursday 11 February 2016 PHILADELPHIA , Feb. 11, 2016 /PRNewswire/ --Lannett Company,... ...

http://in.advfn.com/p.php?pid=nmona&article=70335426
Mylan Full Year Adjusted Diluted EPS Up 21% to $4.30

Mylan N.V. (NASDAQ:MYL) Intraday Stock Chart Today : Thursday 11 February 2016 HERTFORDSHIRE, England and PITTSBURGH , Feb.10, 2016... ...

http://in.advfn.com/p.php?pid=nmona&article=70326577
BPC Statement on FDA Arthritis Advisory Committee Meeting

WASHINGTON , Feb. 9, 2016 /PRNewswire-USNewswire/ -- On Tuesday, February 9th,the U.S. Food and Drug Administration (FDA) met with its Arthritis... ...

http://www.pharmafocusasia.com/pressreleases/bpc-statement-on-fda-arthritis-advisory-committee-meeting

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