Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210557

VYLEESI (AUTOINJECTOR) (BREMELANOTIDE ACETATE)
EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
Marketing Status: Prescription
Active Ingredient: BREMELANOTIDE ACETATE
Proprietary Name: VYLEESI (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210557
Product Number: 001
Approval Date: Jun 21, 2019
Applicant Holder Full Name: PALATIN TECHNOLOGIES INC
Marketing Status:  Prescription
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