Application 072668

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOLOL MALEATE	TIMOLOL MALEATE	TABLET;ORAL	20MG	No	Yes
002	TIMOLOL MALEATE	TIMOLOL MALEATE	TABLET;ORAL	5MG	No	No
003	TIMOLOL MALEATE	TIMOLOL MALEATE	TABLET;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A072668-001	TIMOLOL MALEATE	TIMOLOL MALEATE	20MG	TABLET / ORAL		1990-06-08
A072668-002	TIMOLOL MALEATE	TIMOLOL MALEATE	5MG	TABLET / ORAL		1990-06-08
A072668-003	TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB	1990-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072668-003	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 4 · 126 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	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL			1990-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL			1990-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 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	A072668-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072668-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072668-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072668-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-003	AB	1	`1e350fbaab3a…`

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 Maleate	TIMOLOL MALEATE	Mylan Pharmaceuticals Inc.	57c62928-63d8-4505-9b9e-c085a3a12c95	2020-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072668 application number: ANDA072668 ndc (product): 0378-0055 ndc (product): 0378-0715 ndc (product): 0378-0221

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0055	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0055	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0055	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0055	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0221	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0221	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0221	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0221	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0715	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0715	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0715	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0715	Timolol Maleate	timolol maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
63629-7167	Timolol Maleate	timolol maleate	Bryant Ranch Prepack	ANDA	Current
63629-7167	Timolol Maleate	timolol maleate	Bryant Ranch Prepack	ANDA	Current
69189-0496	Timolol Maleate	timolol maleate	Avera McKennan Hospital	ANDA	Current