Details for New Drug Application (NDA): 212849
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NDA 212849 describes RYKINDO, which is a drug marketed by Shandong Luye and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the RYKINDO profile page.
The generic ingredient in RYKINDO 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 RYKINDO 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 212849
| Tradename: | RYKINDO |
| Applicant: | Shandong Luye |
| Ingredient: | risperidone |
| Patents: | 5 |
Medical Subject Heading (MeSH) Categories for 212849
Suppliers and Packaging for NDA: 212849
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RYKINDO | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212849 | NDA | Shandong Luye Pharmaceutical Co., Ltd. | 72526-101 | 72526-101-11 | 1 KIT in 1 KIT (72526-101-11) * 2 mL in 1 VIAL, SINGLE-DOSE (72526-201-01) * 2 mL in 1 SYRINGE, GLASS (72526-801-01) |
| RYKINDO | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212849 | NDA | Shandong Luye Pharmaceutical Co., Ltd. | 72526-102 | 72526-102-11 | 1 KIT in 1 KIT (72526-102-11) * 2 mL in 1 VIAL, SINGLE-DOSE (72526-202-01) * 2 mL in 1 SYRINGE, GLASS (72526-801-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 12.5MG | ||||
| Approval Date: | Jan 13, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 10, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA IN ADULTS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 10, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA IN ADULTS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 10, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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