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FDA NDA · NDA020811

ACULAR PRESERVATIVE FREE

Sponsor: ALLERGAN

APPLICATION
NDA020811
TYPE
NDA
ORIGINAL APPROVAL
1997-11-03
LATEST ACTION
2002-02-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ACULAR PRESERVATIVE FREEDiscontinued
KETOROLAC TROMETHAMINE 0.5% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2002-02-08Efficacy · Supplement 3 · standardLetterAP
2000-07-07Labeling · Supplement 2 · standardAP
1997-11-03Type 3 - New Dosage Form · Original · standardReviewAP
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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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