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Generated: September 20, 2018

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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 twenty 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 205879
Tradename:INVOKAMET XR
Applicant:Janssen Pharms
Ingredient:canagliflozin; metformin hydrochloride
Patents:6
Pharmacology for NDA: 205879
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;500MG
Approval Date:Sep 20, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 20, 2019
Regulatory Exclusivity Use:AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH CANAGLIFLOZIN AND METFORMIN IS APPROPRIATE
Regulatory Exclusivity Expiration:Mar 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Oct 25, 2021Product Flag?YSubstance Flag?Delist Request?

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