Details for New Drug Application (NDA): 208643
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The generic ingredient in PALIPERIDONE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 208643
Tradename: | PALIPERIDONE |
Applicant: | Lupin Ltd |
Ingredient: | paliperidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 208643
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 208643 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-523 | 68180-523-06 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-523-06) |
PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 208643 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-524 | 68180-524-06 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-524-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
Approval Date: | Jun 29, 2022 | TE: | BX | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
Approval Date: | Jun 29, 2022 | TE: | BX | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
Approval Date: | Jun 29, 2022 | TE: | BX | RLD: | No |
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