← FDA DRUG APPROVALS

FDA NDA · NDA021770

ALPHAGAN P

brimonidine tartrate

Sponsor: ABBVIE

APPLICATION
NDA021770
TYPE
NDA
ORIGINAL APPROVAL
2005-08-19
LATEST ACTION
2025-09-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

ALPHAGAN P · ReferencePrescription
BRIMONIDINE TARTRATE 0.1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-09-18Labeling · Supplement 14 · standard — Letter ↗AP
2016-05-05Manufacturing (CMC) · Supplement 10 · standardAP
2014-03-12Manufacturing (CMC) · Supplement 8 · standardAP
2014-01-22Manufacturing (CMC) · Supplement 9 · standardAP
2013-06-05Manufacturing (CMC) · Supplement 7 · standardAP
2010-08-13Labeling · Supplement 4 · standard — Label ↗AP
2006-04-17Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2005-08-19Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →