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Last Updated: February 1, 2023

Details for New Drug Application (NDA): 204629


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NDA 204629 describes JARDIANCE, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from five suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JARDIANCE profile page.

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
Summary for 204629
Tradename:JARDIANCE
Applicant:Boehringer Ingelheim
Ingredient:empagliflozin
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 204629
Suppliers and Packaging for NDA: 204629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JARDIANCE empagliflozin TABLET;ORAL 204629 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0152 0597-0152-07 1 BOTTLE in 1 CARTON (0597-0152-07) / 7 TABLET, FILM COATED in 1 BOTTLE
JARDIANCE empagliflozin TABLET;ORAL 204629 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0152 0597-0152-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0152-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 1, 2014TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 24, 2025
Regulatory Exclusivity Use:LABELING REVISIONS RELATED TO CLINICAL STUDIES
Regulatory Exclusivity Expiration:Aug 18, 2024
Regulatory Exclusivity Use:REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION
Patent:See Plans and PricingPatent Expiration:Apr 3, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

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