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FDA NDA · NDA020408

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APPLICATION
NDA020408
TYPE
NDA
ORIGINAL APPROVAL
1994-12-09
LATEST ACTION
2020-12-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

TRUSOPT · ReferenceDiscontinued
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2020-12-21Labeling · Supplement 52 · standard — Letter ↗AP
2014-02-03Labeling · Supplement 50 · standard — Label ↗AP
2010-06-18Labeling · Supplement 47 · standard — Label ↗AP
2008-10-22Labeling · Supplement 45 · standard — Letter ↗AP
2005-12-16Labeling · Supplement 39 · standard — Letter ↗AP
2004-04-15Efficacy · Supplement 33 · priority — Pediatric Medical Review ↗AP
2002-12-06Manufacturing (CMC) · Supplement 28 · priorityAP
2002-05-15Labeling · Supplement 25 · standard — Letter ↗AP
2002-05-15Labeling · Supplement 23 · standard — Label ↗AP
2002-04-19Manufacturing (CMC) · Supplement 26 · priorityAP
2002-04-15Manufacturing (CMC) · Supplement 24 · priorityAP
2001-12-04Manufacturing (CMC) · Supplement 22 · priorityAP
2001-01-18Manufacturing (CMC) · Supplement 20 · priorityAP
2000-09-18Labeling · Supplement 21 · standardAP
2000-02-15Labeling · Supplement 19 · standardAP
1999-09-27Labeling · Supplement 17 · standardAP
1999-06-06Labeling · Supplement 16 · standardAP
1998-12-01Labeling · Supplement 15 · standardAP
1998-10-19Manufacturing (CMC) · Supplement 14 · priorityAP
1998-08-03Labeling · Supplement 6 · standardAP
1998-08-03Labeling · Supplement 10 · standardAP
1998-08-03Labeling · Supplement 7 · standardAP
1998-08-03Labeling · Supplement 13 · standardAP
1998-08-03Labeling · Supplement 11 · standardAP
1997-12-12Manufacturing (CMC) · Supplement 12 · priorityAP
1997-06-13Manufacturing (CMC) · Supplement 9 · priorityAP
1997-02-20Manufacturing (CMC) · Supplement 8 · priorityAP
1996-07-22Manufacturing (CMC) · Supplement 5 · priorityAP
1995-10-31Manufacturing (CMC) · Supplement 4 · priorityAP
1995-10-31Manufacturing (CMC) · Supplement 3 · priorityAP
1995-04-25Manufacturing (CMC) · Supplement 1 · priorityAP
1995-03-23Manufacturing (CMC) · Supplement 2 · priorityAP
1994-12-09Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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