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`Page 1 of 3
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`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
`
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`
`Product Details for NDA 022264
`
`Collapse All
`
`INVEGA SUSTENNA (PALIPERIDONE PALMITATE)
`39MG/0.25ML (39MG/0.25ML)
`Marketing Status: Prescription
`
`Active Ingredient: PALIPERIDONE PALMITATE
`Proprietary Name: INVEGA SUSTENNA
`Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE;
`INTRAMUSCULAR
`Strength: 39MG/0.25ML (39MG/0.25ML)
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022264
`Product Number: 001
`Approval Date: Jul 31, 2009
`Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=001&Appl_No=022264&Appl_type=N)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl...
`
`1/22/2020
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1025 p. 001
`
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 3
`
`INVEGA SUSTENNA (PALIPERIDONE PALMITATE)
`78MG/0.5ML (78MG/0.5ML)
`Marketing Status: Prescription
`
`Active Ingredient: PALIPERIDONE PALMITATE
`Proprietary Name: INVEGA SUSTENNA
`Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE;
`INTRAMUSCULAR
`Strength: 78MG/0.5ML (78MG/0.5ML)
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022264
`Product Number: 002
`Approval Date: Jul 31, 2009
`Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=002&Appl_No=022264&Appl_type=N)
`
`INVEGA SUSTENNA (PALIPERIDONE PALMITATE)
`117MG/0.75ML (117MG/0.75ML)
`Marketing Status: Prescription
`
`Active Ingredient: PALIPERIDONE PALMITATE
`Proprietary Name: INVEGA SUSTENNA
`Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE;
`INTRAMUSCULAR
`Strength: 117MG/0.75ML (117MG/0.75ML)
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022264
`Product Number: 003
`Approval Date: Jul 31, 2009
`Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=003&Appl_No=022264&Appl_type=N)
`
`INVEGA SUSTENNA (PALIPERIDONE PALMITATE)
`156MG/ML (156MG/ML)
`Marketing Status: Prescription
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl...
`
`1/22/2020
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1025 p. 002
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 3 of 3
`
`Active Ingredient: PALIPERIDONE PALMITATE
`Proprietary Name: INVEGA SUSTENNA
`Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE;
`INTRAMUSCULAR
`Strength: 156MG/ML (156MG/ML)
`Reference Listed Drug: Yes
`Reference Standard: Yes
`TE Code:
`Application Number: N022264
`Product Number: 004
`Approval Date: Jul 31, 2009
`Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=004&Appl_No=022264&Appl_type=N)
`
`INVEGA SUSTENNA (PALIPERIDONE PALMITATE)
`234MG/1.5ML (156MG/ML)
`Marketing Status: Prescription
`
`Active Ingredient: PALIPERIDONE PALMITATE
`Proprietary Name: INVEGA SUSTENNA
`Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE;
`INTRAMUSCULAR
`Strength: 234MG/1.5ML (156MG/ML)
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022264
`Product Number: 005
`Approval Date: Jul 31, 2009
`Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=005&Appl_No=022264&Appl_type=N)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl...
`
`1/22/2020
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1025 p. 003
`
`