FDA NDA · NDA020490

ALPHAGAN

Sponsor: ALLERGAN

APPLICATION

NDA020490

TYPE

NDA

ORIGINAL APPROVAL

1997-03-13

LATEST ACTION

2025-09-18

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Discontinued

Products

ALPHAGANDiscontinued

BRIMONIDINE TARTRATE 0.5% · SOLUTION/DROPS · OPHTHALMIC

2025-09-18Labeling · Supplement 10 · standard — Letter ↗AP

2016-03-23Labeling · Supplement 8 · standard — Letter ↗AP

2001-12-20Efficacy · Supplement 7 · standard — Review ↗AP

2001-04-09Manufacturing (CMC) · Supplement 6 · standardAP

2000-05-26Manufacturing (CMC) · Supplement 5 · standardAP

1999-08-26Manufacturing (CMC) · Supplement 4 · standardAP

1998-05-20Manufacturing (CMC) · Supplement 3 · standardAP

1998-02-25Manufacturing (CMC) · Supplement 2 · standardAP

1998-01-15Manufacturing (CMC) · Supplement 1 · standardAP

1997-03-13Type 3 - New Dosage Form · Original · 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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