Details for New Drug Application (NDA): 021999
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The generic ingredient in INVEGA is paliperidone palmitate. There are two 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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