Details for New Drug Application (NDA): 218330
✉ Email this page to a colleague
The generic ingredient in PALIPERIDONE is paliperidone. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the paliperidone profile page.
Summary for 218330
| Tradename: | PALIPERIDONE |
| Applicant: | Alembic |
| Ingredient: | paliperidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218330
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 218330 | ANDA | Alembic Pharmaceuticals Limited | 46708-803 | 46708-803-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30) |
| PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 218330 | ANDA | Alembic Pharmaceuticals Limited | 46708-804 | 46708-804-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-804-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Sep 26, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
| Approval Date: | Sep 26, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
| Approval Date: | Sep 26, 2024 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
