Details for New Drug Application (NDA): 216174
✉ Email this page to a colleague
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 216174
Tradename: | PALIPERIDONE |
Applicant: | Ascent Pharms Inc |
Ingredient: | paliperidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 216174
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 216174 | ANDA | Camber Pharmaceuticals, Inc | 31722-317 | 31722-317-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-317-30) |
PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 216174 | ANDA | Camber Pharmaceuticals, Inc | 31722-318 | 31722-318-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-318-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
Approval Date: | Aug 23, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
Approval Date: | Aug 23, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
Approval Date: | Aug 23, 2023 | TE: | AB | RLD: | No |
Complete Access Available with Subscription