Details for New Drug Application (NDA): 211243
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NDA 211243 describes SPRAVATO, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SPRAVATO profile page.
The generic ingredient in SPRAVATO is esketamine hydrochloride. One supplier is listed for this compound. Additional details are available on the esketamine hydrochloride profile page.
The generic ingredient in SPRAVATO is esketamine hydrochloride. One supplier is listed for this compound. Additional details are available on the esketamine hydrochloride profile page.
Summary for 211243
| Tradename: | SPRAVATO |
| Applicant: | Janssen Pharms |
| Ingredient: | esketamine hydrochloride |
| Patents: | 7 |
Suppliers and Packaging for NDA: 211243
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPRAVATO | esketamine hydrochloride | SPRAY;NASAL | 211243 | NDA | Janssen Pharmaceuticals Inc. | 50458-028 | 50458-028-02 | 2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) |
| SPRAVATO | esketamine hydrochloride | SPRAY;NASAL | 211243 | NDA | Janssen Pharmaceuticals Inc. | 50458-028 | 50458-028-03 | 3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | EQ 28MG BASE | ||||
| Approval Date: | Mar 5, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 5, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT). | ||||||||
| Patent: | 10,869,844 | Patent Expiration: | Sep 10, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT | ||||||||
| Patent: | 10,869,844 | Patent Expiration: | Sep 10, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT | ||||||||
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