Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204353

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INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
50MG;500MG
Marketing Status: Prescription

Active Ingredient: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: INVOKAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204353
Product Number: 001
Approval Date: Aug 8, 2014
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
50MG;1GM
Marketing Status: Prescription

Active Ingredient: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: INVOKAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204353
Product Number: 002
Approval Date: Aug 8, 2014
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
150MG;500MG
Marketing Status: Prescription

Active Ingredient: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: INVOKAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204353
Product Number: 003
Approval Date: Aug 8, 2014
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
150MG;1GM
Marketing Status: Prescription

Active Ingredient: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: INVOKAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204353
Product Number: 004
Approval Date: Aug 8, 2014
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information