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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214358
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 20MG BASE/PACKET PELLETS;ORAL Prescription None Yes No
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 30MG BASE/PACKET PELLETS;ORAL Prescription None Yes No
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 40MG BASE/PACKET PELLETS;ORAL Prescription None Yes No
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 50MG BASE/PACKET PELLETS;ORAL Prescription None Yes No
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE/PACKET PELLETS;ORAL Prescription None Yes No
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE/PACKET PELLETS;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/21/2021 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214358s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214358Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214358Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2022 SUPPL-2

Label is not available on this site.

03/25/2022 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214358Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214358Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/25/2022 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214358Orig1s001lbl.pdf
06/21/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214358s000lbl.pdf
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