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Last Updated: November 2, 2024

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 ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SYNJARDY profile page.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-two 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:8
Pharmacology for NDA: 206111
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 0597-0159-18 180 TABLET in 1 BOTTLE (0597-0159-18)
SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0159 0597-0159-60 60 TABLET in 1 BOTTLE (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:Jun 20, 2026
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Dec 20, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:Oct 3, 2034Product Flag?Substance Flag?Delist Request?Y

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