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FDA NDA · NDA214028

VUITY

pilocarpine hydrochloride

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APPLICATION
NDA214028
TYPE
NDA
ORIGINAL APPROVAL
2021-10-28
LATEST ACTION
2023-03-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

VUITY · ReferenceDiscontinued
PILOCARPINE HYDROCHLORIDE 1.25% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2023-03-28Efficacy · Supplement 2 · standard — Letter ↗AP
2023-03-08Manufacturing (CMC) · Supplement 3 — Label ↗AP
2022-08-16Labeling · Supplement 1 · standard — Letter ↗AP
2021-10-28Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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