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Details for New Drug Application (NDA): 204042

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NDA 204042 describes INVOKANA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the INVOKANA profile page.

The generic ingredient in INVOKANA is canagliflozin. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin profile page.

Summary for NDA: 204042

Janssen Pharms

Pharmacology for NDA: 204042

Suppliers and Packaging for NDA: 204042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 204042 NDA Janssen Pharmaceuticals, Inc. 50458-140 50458-140-01 5 TABLET, FILM COATED in 1 BOTTLE (50458-140-01)
TABLET;ORAL 204042 NDA Janssen Pharmaceuticals, Inc. 50458-140 50458-140-10 10 BLISTER PACK in 1 CARTON (50458-140-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 29, 2013TE:RLD:Yes
Patent:7,943,788Patent Expiration:Jul 14, 2027Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Mar 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,943,582Patent Expiration:Feb 26, 2029Product Flag?YSubstance Flag?YDelist Request?

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