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FDA NDA · NDA021079

ALAMAST

Sponsor: SANTEN

APPLICATION
NDA021079
TYPE
NDA
ORIGINAL APPROVAL
1999-09-24
LATEST ACTION
2013-02-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ALAMASTDiscontinued
PEMIROLAST POTASSIUM 0.1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2013-02-15Manufacturing (CMC) · Supplement 14 · priorityAP
2005-05-12Labeling · Supplement 8 · standard — Letter ↗AP
2005-05-12Labeling · Supplement 6 · standard — Letter ↗AP
2002-05-03Manufacturing (CMC) · Supplement 5 · priorityAP
2002-02-20Manufacturing (CMC) · Supplement 4 · priorityAP
2000-12-12Manufacturing (CMC) · Supplement 2 · priorityAP
2000-05-26Manufacturing (CMC) · Supplement 1 · priorityAP
1999-09-24Type 1 - New Molecular Entity · Original · priority — Letter ↗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.

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