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FDA NDA · NDA021127

OPTIVAR

Sponsor: RISING

APPLICATION
NDA021127
TYPE
NDA
ORIGINAL APPROVAL
2000-05-22
LATEST ACTION
2025-09-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

OPTIVAR · ReferenceDiscontinued
AZELASTINE HYDROCHLORIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-09-18Labeling · Supplement 18 · standard — Letter ↗AP
2008-07-03Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2004-09-03Labeling · Supplement 3 · standard — Letter ↗AP
2004-04-30Labeling · Supplement 7 · standard — Label ↗AP
2004-04-30Labeling · Supplement 8 · standard — Label ↗AP
2001-05-04Manufacturing (CMC) · Supplement 1 · standardAP
2001-04-04Manufacturing (CMC) · Supplement 2 · standardAP
2000-05-22Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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