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Details for New Drug Application (NDA): 205879

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NDA 205879 describes INVOKAMET XR, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the INVOKAMET XR profile page.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

Summary for NDA: 205879

Tradename:
INVOKAMET XR
Applicant:
Janssen Pharms
Ingredient:
canagliflozin; metformin hydrochloride
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 205879

Ingredient-typeBiguanides
Mechanism of ActionSodium-Glucose Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 205879

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVOKAMET XR
canagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 205879 NDA Janssen Pharmaceuticals, Inc. 50458-940 50458-940-01 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01)
INVOKAMET XR
canagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 205879 NDA Janssen Pharmaceuticals, Inc. 50458-940 50458-940-02 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;500MG
Approval Date:Sep 20, 2016TE:RLD:No
Patent:6,723,340Patent Expiration:Oct 25, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,943,788Patent Expiration:Jul 14, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,785,403Patent Expiration:Jul 30, 2024Product Flag?YSubstance Flag?Delist Request?


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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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