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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