Details for New Drug Application (NDA): 212807
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The generic ingredient in PALIPERIDONE is paliperidone. There are thirty-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the paliperidone profile page.
Summary for 212807
| Tradename: | PALIPERIDONE |
| Applicant: | Cspc Ouyi |
| Ingredient: | paliperidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212807
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 212807 | ANDA | Tris Pharma Inc | 27808-222 | 27808-222-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-222-01) |
| PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 212807 | ANDA | Tris Pharma Inc | 27808-223 | 27808-223-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-223-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Oct 29, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
| Approval Date: | Oct 29, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
| Approval Date: | Oct 29, 2020 | TE: | AB | RLD: | No | ||||
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