Details for New Drug Application (NDA): 216352
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NDA 216352 describes ERZOFRI, which is a drug marketed by Luye Innomind Pharma and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ERZOFRI profile page.
The generic ingredient in ERZOFRI 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 ERZOFRI 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 216352
| Tradename: | ERZOFRI |
| Applicant: | Luye Innomind Pharma |
| Ingredient: | paliperidone palmitate |
| Patents: | 1 |
Medical Subject Heading (MeSH) Categories for 216352
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 26, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) | ||||||||
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 26, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) | ||||||||
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