← FDA DRUG APPROVALS

FDA NDA · NDA022211

ZIRGAN

ganciclovir

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA022211
TYPE
NDA
ORIGINAL APPROVAL
2009-09-15
LATEST ACTION
2026-01-20
ROUTE
OPHTHALMIC
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

ZIRGAN · ReferencePrescription
GANCICLOVIR 0.15% · GEL · OPHTHALMIC

Approval history

2026-01-20Labeling · Supplement 7 · standard — Letter ↗AP
2014-05-12Manufacturing (CMC) · Supplement 6AP
2014-04-29Manufacturing (CMC) · Supplement 5AP
2014-02-26Manufacturing (CMC) · Supplement 4AP
2009-09-15Type 3 - New Dosage Form · Original · standard — Letter ↗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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