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FDA NDA · NDA210557

VYLEESI

bremelanotide

Sponsor: COSETTE

APPLICATION
NDA210557
TYPE
NDA
ORIGINAL APPROVAL
2019-06-21
LATEST ACTION
2020-10-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VYLEESI (AUTOINJECTOR) · ReferencePrescription
BREMELANOTIDE ACETATE EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) · SOLUTION · SUBCUTANEOUS

Approval history

2020-10-23Labeling · Supplement 2 · standard — Letter ↗AP
2019-06-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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