← FDA DRUG APPROVALS

FDA NDA · NDA022572

MITOSOL

mitomycin

Sponsor: GLAUKOS

APPLICATION
NDA022572
TYPE
NDA
ORIGINAL APPROVAL
2012-02-07
LATEST ACTION
2021-04-23
ROUTE
TOPICAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

MITOSOL · ReferencePrescription
MITOMYCIN 0.2MG/VIAL · FOR SOLUTION · TOPICAL

Approval history

2021-04-23Labeling · Supplement 9 · standard — Letter ↗AP
2020-08-07Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
2017-12-22Labeling · Supplement 5 · standard — Letter ↗AP
2016-01-20Labeling · Supplement 4 · standard — Label ↗AP
2014-09-25Labeling · Supplement 3 · standard — Label ↗AP
2012-02-07Type 3 - New Dosage Form · Original · priority — 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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