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FDA NDA · NDA204251

SIMBRINZA

brinzolamide/brimonidine tartrate

Sponsor: ALCON LABS INC

APPLICATION
NDA204251
TYPE
NDA
ORIGINAL APPROVAL
2013-04-19
LATEST ACTION
2023-05-05
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

SIMBRINZA · ReferencePrescription
BRIMONIDINE TARTRATE 0.2%, BRINZOLAMIDE 1% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2023-05-05Labeling · Supplement 12 · standard — Label ↗AP
2016-06-09Manufacturing (CMC) · Supplement 7 · standardAP
2016-01-20Manufacturing (CMC) · Supplement 1 · standardAP
2016-01-15Manufacturing (CMC) · Supplement 5 · standardAP
2015-11-05Labeling · Supplement 6 · standard — Label ↗AP
2013-04-19Type 4 - New Combination · Original · standard — 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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