You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 208040


✉ Email this page to a colleague

« Back to Dashboard


NDA 208040 describes DABIGATRAN ETEXILATE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex, and Hetero Labs Ltd Iii, and is included in three NDAs. It is available from five 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. Eight suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 208040
Tradename:DABIGATRAN ETEXILATE MESYLATE
Applicant:Alkem Labs Ltd
Ingredient:dabigatran etexilate mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208040
Mechanism of ActionThrombin Inhibitors
Medical Subject Heading (MeSH) Categories for 208040
Suppliers and Packaging for NDA: 208040
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 208040 ANDA Ascend Laboratories, LLC 67877-474 67877-474-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-474-60)
DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 208040 ANDA Ascend Laboratories, LLC 67877-475 67877-475-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-475-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Mar 11, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Mar 11, 2020TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.