Timolol Ophthalmic Gel

Brand(s): Timoptic
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Aton Pharma, Inc. (2014-12-23)
Oldest Current Product: 1993-11-14
License(s): NDA

RxNORM: OPHTHALMIC GEL\TIMOLOL
FDAOB: OPHTHALMIC\SOLUTION, GEL FORMING_DROPS\TIMOLOL MALEATE
SPL Active: OPHTHALMIC\SOLUTION, GEL FORMING, EXTENDED RELEASE\TIMOLOL MALEATE
OPHTHALMIC\SOLUTION\TIMOLOL MALEATE
SPL Moiety: OPHTHALMIC\SOLUTION, GEL FORMING, EXTENDED RELEASE\TIMOLOL: TIMOLOL ANHYDROUS
OPHTHALMIC\SOLUTION\TIMOLOL ANHYDROUS
OPHTHALMIC\SOLUTION\TIMOLOL: TIMOLOL ANHYDROUS

product(s) by strength(s)

timolol 0.0025 mg/mg ophthalmic gel

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	250100810	Timoptic	NDA	Aton Pharma, Inc.	1993-11-14	TIMOLOL MALEATE	OPHTHALMIC	SOLUTION	NDA020330	32e96044-2713-40f2-b6f7-c342a31382d8
2	613140224		NDA	Sandoz Inc	1998-12-24	TIMOLOL MALEATE	OPHTHALMIC	SOLUTION, GEL FORMING, EXTENDED RELEASE	NDA020963	72b0d0ec-832a-4c25-b845-2537ab506354

timolol 0.005 mg/mg ophthalmic gel

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	250100811	Timoptic	NDA	Aton Pharma, Inc.	1993-11-14	TIMOLOL MALEATE	OPHTHALMIC	SOLUTION	NDA020330	32e96044-2713-40f2-b6f7-c342a31382d8
2	250100817		NDA	Aton Pharma, Inc.	1993-11-14	TIMOLOL MALEATE	OPHTHALMIC	SOLUTION	NDA020330	4386a2d5-f577-4768-9efe-7d11a8938644

relabeler product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	521250475	NDA	Remedyrepack Inc.	2013-12-03	TIMOLOL MALEATE	OPHTHALMIC	SOLUTION	250100817	NDA020330	11268176-a549-43d4-a683-beab6dec0d0a
2	548684691	NDA	Physicians Total Care, Inc.	2002-10-16	TIMOLOL MALEATE	OPHTHALMIC	SOLUTION	250100817	NDA020330	75b3b776-5eb8-4381-ade1-5cf0e942d5ed

application(s)

#	id	title	applicant	approved	patent	approved drug
1	NDA020330	TIMOPTIC-XE	VALEANT PHARMACEUTICALS NORTH AMERICA LLC	1993-11-04		NDA020330_001, NDA020330_002
2	NDA020963	TIMOLOL MALEATE	ALCON RESEARCH LTD	1998-10-21	p6174524, SUBSTANCE	NDA020963_001, NDA020963_002

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	TE	approved	application
1	NDA020330_001	RX	TIMOLOL MALEATE (EQ 0.25% BASE)	OPHTHALMIC	SOLUTION, GEL FORMING/DROPS	True	AB	1993-11-04	TIMOPTIC-XE
2	NDA020330_002	RX	TIMOLOL MALEATE (EQ 0.5% BASE)	OPHTHALMIC	SOLUTION, GEL FORMING/DROPS	True	AB	1993-11-04	TIMOPTIC-XE
3	NDA020963_001	RX	TIMOLOL MALEATE (EQ 0.25% BASE)	OPHTHALMIC	SOLUTION, GEL FORMING/DROPS	False	AB	1998-10-21	TIMOLOL MALEATE
4	NDA020963_002	RX	TIMOLOL MALEATE (EQ 0.5% BASE)	OPHTHALMIC	SOLUTION, GEL FORMING/DROPS	False	AB	1998-10-21	TIMOLOL MALEATE

patent(s)

#	id	expiration date	application(s)
1	p6174524 (view patent)	2019-03-26	NDA020963

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	11268176-a549-43d4-a683-beab6dec0d0a (view SPL)	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5%	prescription	Human Prescription	Remedyrepack Inc.		2013-12-03	1	521250475
2	32e96044-2713-40f2-b6f7-c342a31382d8 (view SPL)	TIMOPTIC-XE 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION)	prescription	Human Prescription	Aton Pharma, Inc.	MANUFACTURE	2014-12-19	3	250100810, 250100811
3	4386a2d5-f577-4768-9efe-7d11a8938644 (view SPL)	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5%	prescription	Human Prescription	Aton Pharma, Inc.	MANUFACTURE	2014-12-23	2	250100817, 250100816
4	72b0d0ec-832a-4c25-b845-2537ab506354 (view SPL)	These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS.Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, Sterile topical ophthalmic dropsInitial U.S. Approval: 1978	prescription	Human Prescription	Sandoz Inc		2011-12-14	10	613140224, 613140225
5	75b3b776-5eb8-4381-ade1-5cf0e942d5ed (view SPL)	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5%	prescription	Human Prescription	Physicians Total Care, Inc.	relabel	2012-08-29	1	548684691

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII