Details for New Drug Application (NDA): 211243
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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