FDA NDA · NDA204708

MIRVASO

brimonidine tartrate

Sponsor: GALDERMA LABS LP

APPLICATION

NDA204708

TYPE

NDA

ORIGINAL APPROVAL

2013-08-23

LATEST ACTION

2016-07-27

ROUTE

TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Prescription

Products

MIRVASO · ReferencePrescription

BRIMONIDINE TARTRATE EQ 0.33% BASE · GEL · TOPICAL

2016-07-27Labeling · Supplement 5 · 901 required — Letter ↗AP

2015-09-23Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP

2015-03-03Manufacturing (CMC) · Supplement 2 · standardAP

2014-09-05Manufacturing (CMC) · Supplement 1 · standardAP

2013-08-23Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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