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Last Updated: February 28, 2021

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Generic Companies with Tentative Approvals for: dabigatran etexilate

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dabigatran etexilate Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Teva Pharms Usa	dabigatran etexilate mesylate	208057	EQ 110MG BASE	CAPSULE;ORAL
Alkem Labs Ltd	dabigatran etexilate mesylate	208040	EQ 75MG BASE	CAPSULE;ORAL
Hetero Labs Ltd Iii	dabigatran etexilate mesylate	207961	EQ 150MG BASE	CAPSULE;ORAL
Dr Reddys Labs Ltd	dabigatran etexilate mesylate	208048	EQ 110MG BASE	CAPSULE;ORAL
Dr Reddys Labs Ltd	dabigatran etexilate mesylate	208048	EQ 150MG BASE	CAPSULE;ORAL
Alembic Pharms Ltd	dabigatran etexilate mesylate	208046	EQ 150MG BASE	CAPSULE;ORAL
Alkem Labs Ltd	dabigatran etexilate mesylate	208040	EQ 150MG BASE	CAPSULE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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Serving leading biopharmaceutical companies globally:

Baxter

AstraZeneca

Moodys

Johnson and Johnson

McKinsey

Express Scripts

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