Details for New Drug Application (NDA): 211149
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NDA 211149 describes PALIPERIDONE PALMITATE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. Additional details are available on the PALIPERIDONE PALMITATE profile page.
The generic ingredient in PALIPERIDONE PALMITATE 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.
The generic ingredient in PALIPERIDONE PALMITATE 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 211149
| Tradename: | PALIPERIDONE PALMITATE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | paliperidone palmitate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211149
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 39MG/0.25ML (39MG/0.25ML) | ||||
| Approval Date: | Jul 6, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 78MG/0.5ML (78MG/0.5ML) | ||||
| Approval Date: | Jul 6, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 117MG/0.75ML (117MG/0.75ML) | ||||
| Approval Date: | Jul 6, 2021 | TE: | AB | RLD: | No | ||||
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