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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213879
Company: MSN

Products on ANDA 213879

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213879

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2024	ORIG-2	Tentative Approval		STANDARD		Label is not available on this site.
05/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213879

DABIGATRAN ETEXILATE MESYLATE

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	215233	ALEMBIC
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	208040	ALKEM LABS LTD
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	208070	APOTEX
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	207961	HETERO LABS LTD III
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	213879	MSN
PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022512	BOEHRINGER INGELHEIM

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	215233	ALEMBIC
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	208040	ALKEM LABS LTD
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	208070	APOTEX
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	207961	HETERO LABS LTD III
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	213879	MSN
PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022512	BOEHRINGER INGELHEIM

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