Application 020439

Type: NDA
Sponsor: OAK PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020439-001	BETIMOL	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31
N020439-002	BETIMOL	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020439-002	AT

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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020439-002	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020439-002	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020439-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020439-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-002	AT	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-002	AT	1	`d8e5a09893c0…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020439-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020439-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020439-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020439-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020439-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020439-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020439-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020439-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020439-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020439-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020439-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020439-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020439-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020439-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020439-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020439-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020439-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020439-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020439-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020439-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020439-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020439-002	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020439-001	AT	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020439-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-001	AT	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-002	AT	1	`3a93d1ddd44b…`

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	Exact identifier application applno (NDA): 020439 application number: NDA020439 ndc (product): 82584-002 ndc (product): 82584-001

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68669-522	Betimol	timolol	Vistakon Pharmaceuticals LLC	NDA	Current
68669-525	Betimol	timolol	Vistakon Pharmaceuticals LLC	NDA	Current
76478-001	Betimol	Timolol	Akorn	NDA	Current
76478-001	Betimol	Timolol	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-001	Betimol	Timolol	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719)	NDA	Current
76478-002	Betimol	Timolol	Akorn	NDA	Current
76478-002	Betimol	Timolol	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-002	Betimol	Timolol	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719)	NDA	Current
82584-001	BETIMOL	timolol	Thea Pharma Inc.	NDA	Current
82584-002	BETIMOL	timolol	Thea Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
12579	SUPPL	2004-11-01
24965	SUPPL	2004-10-29