Application 020963

Type: NDA
Sponsor: SANDOZ INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020963-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21
N020963-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020963-001	AB
N020963-002	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 · 84 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
2026-08-18 06:07:40	2026-07	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB		1998-10-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB		1998-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020963-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020963-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020963-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020963-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020963-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020963-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020963-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020963-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020963-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020963-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020963-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020963-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020963-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020963-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020963-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020963-001	6174524	2019-03-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	6174524	2019-03-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020963-001	6174524	2019-03-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020963-002	6174524	2019-03-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020963-001	6174524	2019-03-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020963-002	6174524	2019-03-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020963-001	6174524	2019-03-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020963-002	6174524	2019-03-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol GFS	TIMOLOL MALEATE	Sandoz Inc	72b0d0ec-832a-4c25-b845-2537ab506354	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020963 application number: NDA020963 ndc (product): 61314-224 ndc (product): 61314-225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61314-224	Timolol GFS	timolol maleate	Sandoz Inc	NDA	Current
61314-224	Timolol GFS	timolol maleate	Sandoz Inc	NDA	Current
61314-224	Timolol GFS	timolol maleate	Sandoz Inc	NDA	Current
61314-225	Timolol GFS	timolol maleate	Sandoz Inc	NDA	Current
61314-225	Timolol GFS	timolol maleate	Sandoz Inc	NDA	Current
61314-225	Timolol GFS	timolol maleate	Sandoz Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78584	SUPPL	2024-05-30
78569	SUPPL	2024-05-29
3852	SUPPL	2007-06-14
13819	SUPPL	2007-06-12
26302	SUPPL	2003-07-08
13818	SUPPL	2003-07-08
41843	ORIG	2003-05-22
13817	SUPPL	2003-04-25
35721	ORIG	1998-10-21
3851	ORIG	1998-10-21
53132	ORIG	1900-01-01
53131	ORIG	1900-01-01