APPLICATION
NDA020330
TYPE
NDA
ORIGINAL APPROVAL
1993-11-04
LATEST ACTION
2018-07-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION, GEL FORMING/DROPS
MARKETING STATUS
Prescription
Products
TIMOPTIC-XE · ReferencePrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
TIMOPTIC-XE · ReferencePrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
Approval history
2015-10-20Manufacturing (CMC) · Supplement 30 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 16 · standardAP
2001-12-03Labeling · Supplement 15 · standardAP
2000-09-18Labeling · Supplement 14 · standardAP
1999-06-07Manufacturing (CMC) · Supplement 13 · standardAP
1999-02-02Manufacturing (CMC) · Supplement 12 · standardAP
1998-04-22Manufacturing (CMC) · Supplement 9 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 10 · standardAP
1996-07-18Manufacturing (CMC) · Supplement 6 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 7 · standardAP
1996-04-11Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-14Labeling · Supplement 5 · standardAP
1995-05-18Labeling · Supplement 3 · standardAP
1995-04-25Manufacturing (CMC) · Supplement 4 · standardAP
1994-12-21Labeling · Supplement 2 · standardAP
1994-06-22Manufacturing (CMC) · Supplement 1 · standardAP
1993-11-04Type 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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