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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Deloitte
AstraZeneca
McKinsey
Queensland Health
Argus Health
Express Scripts
Dow
Johnson and Johnson

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206111

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NDA 206111 describes SYNJARDY, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SYNJARDY profile page.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
Summary for 206111
Tradename:SYNJARDY
Applicant:Boehringer Ingelheim
Ingredient:empagliflozin; metformin hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 206111
Ingredient-typeBiguanides
Mechanism of ActionSodium-Glucose Transporter 2 Inhibitors
Suppliers and Packaging for NDA: 206111
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0159 N 0597-0159-18
SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0159 N 0597-0159-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Aug 26, 2015TE:RLD:Yes
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
Regulatory Exclusivity Expiration:Aug 1, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 26, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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