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. Three 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 |
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 | Janssen Pharmaceuticals, Inc. | 50458-550 | 50458-550-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01) |
| INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999 | NDA | Janssen Pharmaceuticals, Inc. | 50458-550 | 50458-550-98 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98) |
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 | ||||
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