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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 one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SYNJARDY profile page.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are 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 NDA: 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 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Aug 26, 2015TE: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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