Details for New Drug Application (NDA): 210655
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NDA 210655 describes PERSERIS KIT, which is a drug marketed by Indivior and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the PERSERIS KIT profile page.
The generic ingredient in PERSERIS KIT is risperidone. There are thirty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
The generic ingredient in PERSERIS KIT is risperidone. There are thirty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 210655
| Tradename: | PERSERIS KIT |
| Applicant: | Indivior |
| Ingredient: | risperidone |
| Patents: | 10 |
Medical Subject Heading (MeSH) Categories for 210655
Suppliers and Packaging for NDA: 210655
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655 | NDA | Indivior Inc. | 12496-0090 | 12496-0090-1 | 1 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5) |
| PERSERIS KIT | risperidone | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 210655 | NDA | Indivior Inc. | 12496-0090 | 12496-0090-9 | 1 KIT in 1 CARTON (12496-0090-9) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 90MG | ||||
| Approval Date: | Jul 27, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 13, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADMINISTRATION OF RISPERIDONE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 13, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING SCHIZOPHRENIA | ||||||||
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