← FDA DRUG APPROVALS

FDA NDA · NDA018086

TIMOPTIC

timolol maleate

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA018086
TYPE
NDA
ORIGINAL APPROVAL
1978-08-17
LATEST ACTION
2021-11-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

TIMOPTIC · ReferencePrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
TIMOPTIC · ReferencePrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-11-17Labeling · Supplement 80 · standard — Letter ↗AP
2016-08-09Labeling · Supplement 76 · standard — Label ↗AP
2011-09-30Labeling · Supplement 75 · standard — Letter ↗AP
2006-04-26Labeling · Supplement 72 · standard — Letter ↗AP
2006-04-26Labeling · Supplement 70 · standard — Label ↗AP
2003-12-22Manufacturing (CMC) · Supplement 60 · priority — Label ↗AP
2002-12-06Manufacturing (CMC) · Supplement 62 · priorityAP
2002-04-29Labeling · Supplement 58 · standard — Letter ↗AP
2002-04-17Manufacturing (CMC) · Supplement 59 · priorityAP
2001-12-05Manufacturing (CMC) · Supplement 57 · priorityAP
2001-11-30Labeling · Supplement 56 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 54 · priority — Letter ↗AP
2000-09-18Labeling · Supplement 53 · standardAP
1998-04-22Manufacturing (CMC) · Supplement 49 · priorityAP
1998-03-18Labeling · Supplement 52 · standard — Review ↗AP
1997-08-05Labeling · Supplement 51 · standardAP
1997-05-16Labeling · Supplement 47 · standard — Review ↗AP
1996-12-02Manufacturing (CMC) · Supplement 50 · priorityAP
1996-07-18Manufacturing (CMC) · Supplement 46 · priorityAP
1996-04-16Manufacturing (CMC) · Supplement 48 · priorityAP
1995-04-25Manufacturing (CMC) · Supplement 45 · priorityAP
1995-02-24Labeling · Supplement 44 · standardAP
1995-02-24Labeling · Supplement 43 · standardAP
1993-12-09Labeling · Supplement 42 · standardAP
1992-05-20Labeling · Supplement 38AP
1992-05-20Labeling · Supplement 37AP
1992-05-20Labeling · Supplement 35AP
1990-03-19Manufacturing (CMC) · Supplement 36 · priorityAP
1988-01-15Manufacturing (CMC) · Supplement 34 · priorityAP
1987-08-04Labeling · Supplement 28AP
1987-08-04Labeling · Supplement 32AP
1987-08-04Labeling · Supplement 14AP
1987-08-04Labeling · Supplement 33AP
1987-06-05Manufacturing (CMC) · Supplement 30 · priorityAP
1986-11-28Manufacturing (CMC) · Supplement 31 · priorityAP
1986-02-27Labeling · Supplement 29AP
1986-02-12Manufacturing (CMC) · Supplement 26 · priorityAP
1984-11-29Manufacturing (CMC) · Supplement 27 · priorityAP
1984-06-14Manufacturing (CMC) · Supplement 24 · priorityAP
1983-09-07Manufacturing (CMC) · Supplement 22 · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →