Details for New Drug Application (NDA): 218514
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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 218514
Tradename: | PALIPERIDONE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | paliperidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 218514
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 218514 | ANDA | Ajanta Pharma USA Inc. | 27241-276 | 27241-276-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-276-30) |
PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 218514 | ANDA | Ajanta Pharma USA Inc. | 27241-277 | 27241-277-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-277-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
Approval Date: | Jun 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: | Jun 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: | Jun 26, 2024 | TE: | AB | RLD: | No |
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