Application 020330

Type: NDA
Sponsor: VALEANT PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOPTIC-XE	TIMOLOL MALEATE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	EQ 0.25% BASE	Yes	Yes
002	TIMOPTIC-XE	TIMOLOL MALEATE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	EQ 0.5% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020330-001	TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04
N020330-002	TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020330-001	AB
N020330-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1993-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1993-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020330-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020330-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020330-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020330-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020330-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020330-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020330-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020330-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020330-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020330-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020330-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020330-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020330-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020330-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020330-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020330-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020330-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020330-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	581f80f7-4419-49e2-867d-40443c75409f	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020330 application number: NDA020330 ndc (product): 82260-818 ndc (product): 82260-819
Timoptic-XE	TIMOLOL MALEATE	Bausch & Lomb Incorporated	a4d03de7-06b7-4cfc-9d1b-616969df209c	2022-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020330 application number: NDA020330 ndc (product): 24208-814 ndc (product): 24208-816

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-814	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-814	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-814	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-814	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-816	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-816	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-816	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-816	Timoptic-XE	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-818	Timolol Maleate	Timolol Maleate	Bausch & Lomb Incorporated	NDA AUTHORIZED GENERIC	Current
24208-818	Timolol Maleate	Timolol Maleate	Bausch & Lomb Incorporated	NDA AUTHORIZED GENERIC	Current
24208-819	Timolol Maleate	Timolol Maleate	Bausch & Lomb Incorporated	NDA AUTHORIZED GENERIC	Current
24208-819	Timolol Maleate	Timolol Maleate	Bausch & Lomb Incorporated	NDA AUTHORIZED GENERIC	Current
82260-818	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current
82260-818	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current
82260-819	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current
82260-819	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54930	SUPPL	2018-07-20
54906	SUPPL	2018-07-17
12454	SUPPL	2015-10-15
2342	SUPPL	2015-10-13
24788	SUPPL	2011-10-04
34512	SUPPL	2011-09-30
41283	SUPPL	2006-05-08
34511	SUPPL	2006-05-01
34510	SUPPL	2006-05-01
24787	SUPPL	2006-05-01
2341	SUPPL	2006-05-01
34509	SUPPL	2004-08-12
12453	SUPPL	2004-08-12
2340	SUPPL	2004-08-12
2339	SUPPL	2004-08-12
34508	SUPPL	2003-12-29
2338	SUPPL	2003-12-24
41282	SUPPL	2003-09-11