APPLICATION
NDA020613
TYPE
NDA
ORIGINAL APPROVAL
1996-09-06
LATEST ACTION
2016-03-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
ALPHAGAN · ReferenceDiscontinued
BRIMONIDINE TARTRATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
2013-06-06Manufacturing (CMC) · Supplement 30 · standardAP
2003-03-19Labeling · Supplement 24 · standardAP
2002-05-16Manufacturing (CMC) · Supplement 19 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 20 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 17 · standardAP
2001-07-13Manufacturing (CMC) · Supplement 12 · standardAP
2001-05-14Manufacturing (CMC) · Supplement 15 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 16 · standardAP
2001-04-09Manufacturing (CMC) · Supplement 13 · standardAP
2001-04-09Manufacturing (CMC) · Supplement 14 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 11 · standardAP
2000-05-26Manufacturing (CMC) · Supplement 10 · standardAP
1999-12-13Labeling · Supplement 8 · standardAP
1999-12-13Labeling · Supplement 6 · standardAP
1999-08-26Manufacturing (CMC) · Supplement 7 · standardAP
1998-05-20Manufacturing (CMC) · Supplement 4 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 3 · standardAP
1998-01-15Manufacturing (CMC) · Supplement 2 · standardAP
1997-05-29Manufacturing (CMC) · Supplement 1 · standardAP
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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