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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214358


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NDA 214358 describes PRADAXA, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from four suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRADAXA profile page.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 214358
Tradename:PRADAXA
Applicant:Boehringer Ingelheim
Ingredient:dabigatran etexilate mesylate
Patents:1
Pharmacology for NDA: 214358
Mechanism of ActionThrombin Inhibitors
Medical Subject Heading (MeSH) Categories for 214358
Suppliers and Packaging for NDA: 214358
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0425 0597-0425-78 1 BAG in 1 CARTON (0597-0425-78) / 60 PELLET in 1 BAG
PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0430 0597-0430-18 1 BAG in 1 CARTON (0597-0430-18) / 60 PELLET in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrengthEQ 20MG BASE/PACKET
Approval Date:Jun 21, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Dec 21, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:Mar 7, 2026Product Flag?Substance Flag?Delist Request?Y

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