Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209963

GOPRELTO (COCAINE HYDROCHLORIDE)
4%
Marketing Status: Prescription
Active Ingredient: COCAINE HYDROCHLORIDE
Proprietary Name: GOPRELTO
Dosage Form; Route of Administration: SOLUTION; NASAL
Strength: 4%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209963
Product Number: 001
Approval Date: Dec 14, 2017
Applicant Holder Full Name: GENUS LIFE SCIENCES INC
Marketing Status:  Prescription
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