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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 207922

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NDA 207922 describes DABIGATRAN ETEXILATE MESYLATE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys, Hetero Labs Ltd Iii, MSN, and Mylan, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the DABIGATRAN ETEXILATE MESYLATE profile page.

The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.

Summary for 207922

Tradename:	DABIGATRAN ETEXILATE MESYLATE
Applicant:	Breckenridge
Ingredient:	dabigatran etexilate mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 207922

Antithrombins

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Dec 19, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Dec 19, 2024	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 110MG BASE
Approval Date:	Dec 19, 2024	TE:		RLD:	No

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