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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 one supplier. There are three patents protecting this drug. Additional details are available on the JARDIANCE profile page.

The generic ingredient in JARDIANCE is empagliflozin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin profile page.

Summary for NDA: 204629

Tradename:
JARDIANCE
Applicant:
Boehringer Ingelheim
Ingredient:
empagliflozin
Patents:3

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 1, 2014TE:RLD:No
Patent:7,579,449Patent Expiration:Nov 5, 2025Product Flag?Substance Flag?YDelist Request?
Patent:7,713,938Patent Expiration:Apr 15, 2027Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Mar 18, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN


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