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Abbreviated New Drug Application

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Dr Reddy's buys 8 US drugs from Teva, Allergan for $350 million

This includes seven products which are pending US Food and Drugs Administration approval (abbreviated new drug application) and an approved product spread across diverse dosage forms. Dr......

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......
  Web results for Abbreviated New Drug Application
Sensex Opens Deep in Red, Pharma Stocks Continue to Slide

Posted by Equitymaster Asian stock markets are lower in morning trade tracking losses in Wall Street. The Nikkei 225 is off 2.01% while the Hang... ...

http://feeds.equitymaster.com/~r/TodaysMarket/~3/NocLEa6sAek/tm.asp
Wockhardt gets USFDA approval for ANDA of Piperacillin and Tazobactam for Injection USP

This is to inform the Exchanges that abbreviated new drug application(ANDA) of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy... ...

http://www.moneycontrol.com/news/announcements/wockhardt-gets-usfda-approval-for-andapiperacillintazobactam-for-injection-usp_8671861.html
How Dr Reddy's plans to win the US market

The company has launched only 3 new products during 2015 when compared to 14 launches in 2014 Dr Reddy’s Laboratories (DRL) is likely to... ...

http://www.rediff.com/money/report/how-dr-reddys-plans-to-win-the-us-market/20170317.htm
US FDA ban on Sun Pharma unit lifted after over 3 years

The US Food and Drug Administration (FDA) said it would remove the nearly three-year old import sanction on Sun Pharma's Mohali plant which would... ...

http://www.business-standard.com/article/companies/investors-cheer-sun-pharma-on-fda-removal-of-import-alert-117031400843_1.html
Zydus Cadila gets USFDA nod to market muscle relaxant in US

Drug firm Zydus Cadila has received approval from the USFDA to market tizanidine hydrochloride capsules, a muscle relaxant, in the American market.... ...

http://www.business-standard.com/article/pti-stories/zydus-cadila-gets-usfda-nod-to-market-muscle-relaxant-in-us-117030800303_1.html

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