Application 019219

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	BETAGAN	LEVOBUNOLOL HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.5%	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019219-002	BETAGAN	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019219-002	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 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019219-002	BETAGAN	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1985-12-19	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N019219-002	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019219-002	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019219-002	AT	1	`a50c72e98297…`

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
Levobunolol Hydrochloride	LEVOBUNOLOL HYDROCHLORIDE	Bausch & Lomb Incorporated	5ab1efbe-530b-4787-b40a-c7dbf18161e1	2024-07-24	Warnings, Adverse reactions	Name fallback generic name: LEVOBUNOLOL HYDROCHLORIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-4385	BETAGAN	levobunolol hydrochloride	Allergan, Inc.	NDA	Current
0023-4385	BETAGAN	levobunolol hydrochloride	Allergan, Inc.	NDA	Current
0023-4385	BETAGAN	levobunolol hydrochloride	Allergan, Inc.	NDA	Current
60758-060	LEVOBUNOLOL HYDROCHLORIDE	levobunolol hydrochloride	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-060	LEVOBUNOLOL HYDROCHLORIDE	levobunolol hydrochloride	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-060	LEVOBUNOLOL HYDROCHLORIDE	levobunolol hydrochloride	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57629	ORIG	2019-02-15
50931	SUPPL	2017-12-27
50912	SUPPL	2017-12-27
11454	SUPPL	2003-04-15