APPLICATION
NDA018061
TYPE
NDA
ORIGINAL APPROVAL
1981-12-11
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TIMOLIDE 10-25Discontinued
HYDROCHLOROTHIAZIDE 25MG, TIMOLOL MALEATE 10MG · TABLET · ORAL
Approval history
2009-03-13Efficacy · Supplement 2AP
2002-04-05Manufacturing (CMC) · Supplement 30 · standardAP
1998-10-13Labeling · Supplement 25 · standardAP
1998-05-15Labeling · Supplement 28 · standardAP
1998-05-04Manufacturing (CMC) · Supplement 26 · standardAP
1998-02-13Manufacturing (CMC) · Supplement 27 · standardAP
1997-07-09Manufacturing (CMC) · Supplement 24 · standardAP
1994-02-09Labeling · Supplement 23 · standardAP
1993-01-22Labeling · Supplement 22 · standardAP
1991-08-12Labeling · Supplement 21AP
1989-04-21Manufacturing (CMC) · Supplement 20 · standardAP
1988-08-15Manufacturing (CMC) · Supplement 15 · standardAP
1988-02-03Efficacy · Supplement 4AP
1988-02-03Labeling · Supplement 19AP
1987-08-26Labeling · Supplement 16AP
1987-06-01Manufacturing (CMC) · Supplement 18 · standardAP
1987-04-08Labeling · Supplement 17AP
1986-08-08Manufacturing (CMC) · Supplement 14 · standardAP
1986-06-02Labeling · Supplement 13AP
1985-09-06Labeling · Supplement 12AP
1984-10-04Labeling · Supplement 11AP
1984-04-18Labeling · Supplement 10AP
1983-12-23Manufacturing (CMC) · Supplement 8 · standardAP
1983-08-24Labeling · Supplement 9AP
1982-09-20Labeling · Supplement 6AP
1982-09-20Labeling · Supplement 5AP
1982-05-07Manufacturing (CMC) · Supplement 1 · standardAP
1982-02-24Manufacturing (CMC) · Supplement 3 · standardAP
1981-12-11Type 4 - New Combination · Original · standardAP
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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