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DewDiligence

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Re: iwfal post# 125388

Sunday, 08/21/2011 11:45:05 AM

Sunday, August 21, 2011 11:45:05 AM

Post# of 257253
If you’re referring to the ANDA pathway, specifically, the record (as far as I know) is 59 months for NVS/MNTA’s approval of Lovenox. The Cenestin/Premarin application took longer, but Cenestin was ultimately approved under 505b2 and there was a gap in the middle of the timeline between the rejection of the ANDA and the submission of the 505b2 application.

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