APPLICATION
NDA018017
TYPE
NDA
ORIGINAL APPROVAL
1981-11-25
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BLOCADREN · ReferenceDiscontinued
TIMOLOL MALEATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BLOCADREN · ReferenceDiscontinued
TIMOLOL MALEATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BLOCADREN · ReferenceDiscontinued
TIMOLOL MALEATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Efficacy · Supplement 8AP
2009-03-13Efficacy · Supplement 4AP
2009-03-13Efficacy · Supplement 16AP
2001-12-17Manufacturing (CMC) · Supplement 35 · priorityAP
1998-05-15Labeling · Supplement 33 · standardAP
1998-05-04Manufacturing (CMC) · Supplement 31 · priorityAP
1998-02-13Manufacturing (CMC) · Supplement 32 · priorityAP
1997-04-18Manufacturing (CMC) · Supplement 30 · priorityAP
1997-04-18Manufacturing (CMC) · Supplement 29 · priorityAP
1994-02-09Labeling · Supplement 28 · standardAP
1991-04-17Labeling · Supplement 26AP
1990-03-08Efficacy · Supplement 11AP
1989-06-05Manufacturing (CMC) · Supplement 25 · priorityAP
1988-08-15Manufacturing (CMC) · Supplement 21 · priorityAP
1987-12-11Labeling · Supplement 20AP
1987-06-01Manufacturing (CMC) · Supplement 24 · priorityAP
1987-03-24Labeling · Supplement 23AP
1987-03-24Labeling · Supplement 18AP
1986-08-12Manufacturing (CMC) · Supplement 22 · priorityAP
1985-08-08Manufacturing (CMC) · Supplement 19 · priorityAP
1985-02-25Labeling · Supplement 15AP
1985-02-25Efficacy · Supplement 14AP
1985-01-02Labeling · Supplement 17AP
1983-12-23Manufacturing (CMC) · Supplement 10 · priorityAP
1983-09-23Manufacturing (CMC) · Supplement 9 · priorityAP
1983-08-29Labeling · Supplement 13AP
1983-08-29Labeling · Supplement 12AP
1983-07-22Labeling · Supplement 6AP
1982-09-20Labeling · Supplement 7AP
1982-09-20Labeling · Supplement 1AP
1982-05-07Labeling · Supplement 3AP
1982-04-09Manufacturing (CMC) · Supplement 5 · priorityAP
1982-03-03Manufacturing (CMC) · Supplement 2 · priorityAP
1981-11-25Type 3 - New Dosage Form · Original · priorityAP
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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