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FDA NDA · NDA019463
TIMOPTIC IN OCUDOSE
timolol maleate
Sponsor: BAUSCH AND LOMB INC
APPLICATION
NDA019463
TYPE
NDA
ORIGINAL APPROVAL
1986-11-05
LATEST ACTION
2017-04-06
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TIMOPTIC IN OCUDOSE · ReferencePrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
TIMOPTIC IN OCUDOSE · ReferencePrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2015-08-14Manufacturing (CMC) · Supplement 30 · standardAP
2002-07-26Manufacturing (CMC) · Supplement 24 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 23 · standardAP
2000-03-02Manufacturing (CMC) · Supplement 21 · standardAP
2000-03-02Labeling · Supplement 20 · standardAP
1998-08-14Manufacturing (CMC) · Supplement 17 · standardAP
1998-04-22Manufacturing (CMC) · Supplement 14 · standardAP
1997-06-22Manufacturing (CMC) · Supplement 18 · standardAP
1997-05-16Labeling · Supplement 13 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 15 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 16 · standardAP
1995-07-10Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-18Labeling · Supplement 11 · standardAP
1993-12-09Labeling · Supplement 9 · standardAP
1993-03-25Manufacturing (CMC) · Supplement 6 · standardAP
1992-05-21Labeling · Supplement 4AP
1992-05-21Labeling · Supplement 5AP
1990-07-09Manufacturing (CMC) · Supplement 3 · standardAP
1989-08-09Manufacturing (CMC) · Supplement 1 · standardAP
1986-11-05Type 3 - New Dosage Form · 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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