Details for New Drug Application (NDA): 207946
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NDA 207946 describes INVEGA TRINZA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the INVEGA TRINZA profile page.
The generic ingredient in INVEGA TRINZA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
The generic ingredient in INVEGA TRINZA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 207946
| Tradename: | INVEGA TRINZA |
| Applicant: | Janssen Pharms |
| Ingredient: | paliperidone palmitate |
| Patents: | 4 |
Suppliers and Packaging for NDA: 207946
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INVEGA HAFYERA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946 | NDA | Janssen Pharmaceuticals, Inc | 50458-606 | 50458-606-01 | 1 SYRINGE in 1 KIT (50458-606-01) / 1 mL in 1 SYRINGE |
| INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946 | NDA | Janssen Pharmaceuticals, Inc | 50458-606 | 50458-606-01 | 1 SYRINGE in 1 KIT (50458-606-01) / 1 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 273MG/0.875ML (273MG/0.875ML) | ||||
| Approval Date: | May 18, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 5, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 5, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 410MG/1.315ML (311.79MG/ML) | ||||
| Approval Date: | May 18, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 5, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO | ||||||||
Expired US Patents for NDA 207946
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-003 | May 18, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-001 | May 18, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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