Details for New Drug Application (NDA): 022264
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The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 022264
Tradename: | INVEGA SUSTENNA |
Applicant: | Janssen Pharms |
Ingredient: | paliperidone palmitate |
Patents: | 1 |
Suppliers and Packaging for NDA: 022264
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264 | NDA | Janssen Pharmaceuticals, Inc. | 50458-560 | 50458-560-01 | 1 SYRINGE in 1 KIT (50458-560-01) / .25 mL in 1 SYRINGE |
INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264 | NDA | Janssen Pharmaceuticals, Inc. | 50458-561 | 50458-561-01 | 1 SYRINGE in 1 KIT (50458-561-01) / .5 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 39MG/0.25ML (39MG/0.25ML) | ||||
Approval Date: | Jul 31, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS |
Expired US Patents for NDA 022264
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-005 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-005 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
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