Details for New Drug Application (NDA): 021999
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The generic ingredient in INVEGA 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 021999
Tradename: | INVEGA |
Applicant: | Janssen Pharms |
Ingredient: | paliperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021999
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999 | NDA AUTHORIZED GENERIC | Patriot Pharmaceuticals, LLC | 10147-0952 | 10147-0952-3 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10147-0952-3) |
INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999 | NDA AUTHORIZED GENERIC | Patriot Pharmaceuticals, LLC | 10147-0953 | 10147-0953-3 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10147-0953-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
Approval Date: | Dec 19, 2006 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
Approval Date: | Dec 19, 2006 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 9MG | ||||
Approval Date: | Dec 19, 2006 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021999
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-004 | Dec 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-002 | Dec 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-006 | Aug 26, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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