← FDA DRUG APPROVALS

FDA NDA · NDA020869

COSOPT

dorzolamide hydrochloride and timolol maleate

Sponsor: THEA PHARMA

APPLICATION
NDA020869
TYPE
NDA
ORIGINAL APPROVAL
1998-04-07
LATEST ACTION
2020-11-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

COSOPT · ReferencePrescription
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2020-11-23Labeling · Supplement 42 · standard — Label ↗AP
2015-07-31Labeling · Supplement 40 · standard — Label ↗AP
2010-06-18Labeling · Supplement 36 · standard — Label ↗AP
2008-10-22Labeling · Supplement 34 · standard — Label ↗AP
2006-08-09Labeling · Supplement 30 · standard — Letter ↗AP
2006-04-26Labeling · Supplement 28 · standard — Letter ↗AP
2006-04-26Labeling · Supplement 26 · standard — Letter ↗AP
2005-12-09Labeling · Supplement 22 · standard — Letter ↗AP
2005-03-28Labeling · Supplement 20 · standard — Label ↗AP
2002-12-06Manufacturing (CMC) · Supplement 15 · standardAP
2002-08-28Manufacturing (CMC) · Supplement 11 · standardAP
2002-05-16Manufacturing (CMC) · Supplement 13 · standardAP
2002-04-23Labeling · Supplement 12 · standard — Letter ↗AP
2001-12-04Manufacturing (CMC) · Supplement 9 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 10 · standardAP
2001-07-24Manufacturing (CMC) · Supplement 8 · standardAP
2001-07-19Manufacturing (CMC) · Supplement 7 · standardAP
2000-11-21Manufacturing (CMC) · Supplement 5 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 2 · standardAP
2000-08-24Labeling · Supplement 6 · standardAP
2000-01-23Labeling · Supplement 3 · standardAP
1999-01-04Labeling · Supplement 1 · standard — Review ↗AP
1998-04-07Type 4 - New Combination · Original · standard — Review ↗AP
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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