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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211243

SPRAVATO (ESKETAMINE HYDROCHLORIDE)
EQ 28MG BASE
Marketing Status: Prescription
Active Ingredient: ESKETAMINE HYDROCHLORIDE
Proprietary Name: SPRAVATO
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: EQ 28MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211243
Product Number: 001
Approval Date: Mar 5, 2019
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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