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FDA NDA · NDA217064

RYZUMVI

phentolamine mesylate

Sponsor: FAMYGEN LIFE SCI

APPLICATION
NDA217064
TYPE
NDA
ORIGINAL APPROVAL
2023-09-25
LATEST ACTION
2026-03-12
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RYZUMVI · ReferencePrescription
PHENTOLAMINE MESYLATE EQ 0.75% BASE · SOLUTION · OPHTHALMIC

Approval history

2026-03-12Manufacturing (CMC) · Supplement 4 — Label ↗AP
2023-11-28Labeling · Supplement 1 · standard — Label ↗AP
2023-09-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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