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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 208070


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NDA 208070 describes DABIGATRAN ETEXILATE MESYLATE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and MSN, and is included in five NDAs. It is available from nine 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. Thirteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 208070
Tradename:DABIGATRAN ETEXILATE MESYLATE
Applicant:Apotex
Ingredient:dabigatran etexilate mesylate
Patents:0
Pharmacology for NDA: 208070
Mechanism of ActionThrombin Inhibitors
Medical Subject Heading (MeSH) Categories for 208070
Suppliers and Packaging for NDA: 208070
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 208070 ANDA Apotex Corp. 60505-4347 60505-4347-2 10 BLISTER PACK in 1 CARTON (60505-4347-2) / 6 CAPSULE in 1 BLISTER PACK
DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 208070 ANDA Apotex Corp. 60505-4347 60505-4347-6 60 CAPSULE in 1 BOTTLE (60505-4347-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Dec 15, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 110MG BASE
Approval Date:Dec 15, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Dec 15, 2023TE:ABRLD:No

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