Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214358
Company: BOEHRINGER INGELHEIM

• Medication Guide

Products on NDA 214358

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214358

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
11/14/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214358s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214358Orig1s007ltr.pdf
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

Labels for NDA 214358

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214358s007lbl.pdf
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