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Withdraws Nod to 27
8/23/2012 6:27:21 AM
The US Food and Drug Administration has withdrawn approval given to 27 generic products of Ranbaxy Laboratories. In a letter posted on its website, the regulator said Ranbaxy had requested for withdrawal of approval to 27 of its abbreviated new drug applications (ANDAs) under a consent decree it entered in January this year. The 27 drugs include certain antibiotic capsules and oral suspensions, and drugs for fungal infection and diabetes. A Ranbaxy spokesperson said these products do not pertain to the current business of the company and hence will have negligible impact.
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Ranbaxy Laboratories Limited
Clinical - BLA/NDA/ANDA