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Author: Admin | 2025-04-28
Was approved by FDA for market use on 19 October, 2010. NCE-1 date: NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Pradaxa is 19 October, 2010, its NCE-1 date is estimated to be 22 December, 2023. Treatment: Pradaxa is used for preventing and treating blood clots. Dosage: Pradaxa is available in the following dosage forms - capsule form for oral use, pellets form for oral use. Given below is detailed information on Dosage - Strength Dosage Form Availability Application Pathway EQ 75MG BASE CAPSULE Prescription ORALEQ 150MG BASE CAPSULE Prescription ORALEQ 110MG BASE CAPSULE Prescription ORALEQ 20MG BASE/PACKET PELLETS Prescription ORALEQ 150MG BASE/PACKET PELLETS Prescription ORALEQ 110MG BASE/PACKET PELLETS Prescription ORALEQ 50MG BASE/PACKET PELLETS Prescription ORALEQ 40MG BASE/PACKET PELLETS Prescription ORALEQ 30MG BASE/PACKET PELLETS Prescription ORAL Related content Have Questions?
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