Search For "abbreviated new drug application anda"
Lyrus Receives US FDA Approval for Critical UTI Treatment in the US
Updated : 2 years, 3 months ago IST
Bengaluru (Karnataka) [India], December 15: The U.S. Food and Drug Administration (FDA) has approved Lyrus Life Sciences's Abbreviated New Drug Application (ANDA) for 'Methenamine Hippurate Tablets USP, 1 gram', an AB-rated, substitutable generic version of Hiprex® from Validus Pharmace
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Cipla receives final approval for generic version of GlaxoSmithKline's IMI
Updated : 5 years ago IST
Mumbai (Maharashtra) [India], March 2 (ANI/PRNewswire): Cipla Limited today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the United States Food and Drug Administration (U.S. FDA).
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Indian pharma compliance standards improving, regulatory risks here to sta
Updated : 5 years, 8 months ago IST
Mumbai (Maharashtra) [India], July 7 (ANI): Indian pharmaceutical companies have built a strong abbreviated new drug application (ANDA) pipeline since FY12 through scaling-up of investments in R&D but this will increase the inspection intensity, India Ratings and Research (Ind-Ra) said o
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Cipla receives final approval for generic version of AstraZeneca Pharmaceu
Updated : 5 years, 12 months ago IST
Mumbai (Maharashtra) [India], Mar 27 (ANI/ PRNewswire): Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and hereafter referred to as "Cipla" today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40m
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