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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208040
Company: ALKEM LABS LTD

Products on ANDA 208040

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 110MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2024	ORIG-2	Approval		STANDARD		Label is not available on this site.
03/11/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208040Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2024	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/16/2024	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208040

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	208039	AUROBINDO PHARMA
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	208048	DR REDDYS
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
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	208067	MYLAN
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	208039	AUROBINDO PHARMA
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	208048	DR REDDYS
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
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	208067	MYLAN
PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022512	BOEHRINGER INGELHEIM

CAPSULE;ORAL; EQ 110MG 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 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	215233	ALEMBIC
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	208040	ALKEM LABS LTD
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	208070	APOTEX
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	208039	AUROBINDO PHARMA
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	208048	DR REDDYS
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	207961	HETERO LABS LTD III
DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	No	AB	213879	MSN
PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	022512	BOEHRINGER INGELHEIM

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