Application 205309

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOLOL	TIMOLOL	SOLUTION/DROPS;OPHTHALMIC	EQ 0.25% BASE	No	No
002	TIMOLOL	TIMOLOL	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	No	No

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
A205309-001	TIMOLOL	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC			2016-09-30
A205309-002	TIMOLOL	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC			2016-09-30

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205309-001	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205309-002	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2016-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205309-001	TIMOLOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205309-002	TIMOLOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2016-09-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205309-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205309-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205309-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205309-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205309-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205309-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205309-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205309-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205309-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205309-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205309-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205309-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205309-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205309-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205309-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205309-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205309-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205309-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205309-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205309-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205309-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205309-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205309-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205309-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205309-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205309-002	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A205309-001	AT	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205309-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205309-001	AT	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205309-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205309-001	AT	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205309-002	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205309-001	AT	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A205309-002	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205309-001	AT	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205309-002	AT	1	`cb3db0bc1861…`

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
BETIMOL	TIMOLOL	Thea Pharma Inc.	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	2025-06-27	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL

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
17478-365	Timolol Maleate	Timolol	Akorn, Inc.	ANDA	Current
17478-365	Timolol Maleate	Timolol	Akorn	ANDA	Current
17478-365	Timolol Maleate	Timolol	Akorn, Inc.	ANDA	Current
17478-366	Timolol Maleate	Timolol	Akorn, Inc.	ANDA	Current
17478-366	Timolol Maleate	Timolol	Akorn	ANDA	Current
17478-366	Timolol Maleate	Timolol	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45589	ORIG	2016-10-05