Details for New Drug Application (NDA): 218330
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NDA 218330 describes PALIPERIDONE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, Zydus Pharms, and Teva Pharms Usa, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the PALIPERIDONE profile page.
The generic ingredient in PALIPERIDONE 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 PALIPERIDONE 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 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 | ||||
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