Application 022184

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUMIGAN	BIMATOPROST	SOLUTION/DROPS;OPHTHALMIC	0.01%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022184-001	LUMIGAN	BIMATOPROST	0.01%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2010-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022184-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022184-001	7851504	2027-06-13		Drug substance, Drug product

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2010-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2010-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2010-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022184-001	LUMIGAN	0.01%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-08-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022184-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022184-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022184-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 509 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022184-001	7851504	2027-06-13		Drug substance, Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8278353	2025-03-16		Drug product	2012-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8299118	2025-03-16	U-1295		2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8309605	2025-03-16	U-1293		2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8309605	2025-03-16	U-1294		2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8338479	2025-03-16	U-1295	Drug product	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8524777	2025-03-16	U-1235		2013-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8586630	2025-03-16	U-1458			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8772338	2025-03-16	U-1528	Drug product	2014-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8933120	2025-03-16		Drug product	2015-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	8933127	2025-03-16		Drug product	2015-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	9155716	2025-03-16	U-1528	Drug product	2015-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	9241918	2025-03-16	U-1814	Drug product	2016-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022184-001	7851504	2027-06-13		Drug substance, Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8278353	2025-03-16		Drug product	2012-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8299118	2025-03-16	U-1295		2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8309605	2025-03-16	U-1293		2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8309605	2025-03-16	U-1294		2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8338479	2025-03-16	U-1295	Drug product	2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8524777	2025-03-16	U-1235		2013-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8586630	2025-03-16	U-1458			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8772338	2025-03-16	U-1528	Drug product	2014-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8933120	2025-03-16		Drug product	2015-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	8933127	2025-03-16		Drug product	2015-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	9155716	2025-03-16	U-1528	Drug product	2015-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	9241918	2025-03-16	U-1814	Drug product	2016-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022184-001	7851504	2027-06-13		Drug substance, Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8278353	2025-03-16		Drug product	2012-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8299118	2025-03-16	U-1295		2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8309605	2025-03-16	U-1293		2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8309605	2025-03-16	U-1294		2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8338479	2025-03-16	U-1295	Drug product	2012-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8524777	2025-03-16	U-1235		2013-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8586630	2025-03-16	U-1458			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8772338	2025-03-16	U-1528	Drug product	2014-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8933120	2025-03-16		Drug product	2015-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	8933127	2025-03-16		Drug product	2015-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	9155716	2025-03-16	U-1528	Drug product	2015-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	9241918	2025-03-16	U-1814	Drug product	2016-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022184-001	7851504	2027-06-13		Drug substance, Drug product		`fd3edfee7708…`

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
LUMIGAN	BIMATOPROST	Allergan, Inc.	a5e67c75-db88-4372-bb07-c8dd15c97631	2024-06-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022184 application number: NDA022184 ndc (product): 0023-3205

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-3205	LUMIGAN	bimatoprost	Allergan, Inc.	NDA	Current
0023-3205	LUMIGAN	bimatoprost	Allergan, Inc.	NDA	Current
0023-3205	LUMIGAN	bimatoprost	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70487	SUPPL	2022-03-11
70440	SUPPL	2022-03-09
64772	SUPPL	2020-10-01
64758	SUPPL	2020-09-30
49196	SUPPL	2017-08-02
49168	SUPPL	2017-07-29
29365	SUPPL	2014-10-02
38345	SUPPL	2014-09-30
29364	SUPPL	2012-03-19
17051	SUPPL	2012-03-16
44694	ORIG	2011-02-17
21953	ORIG	2010-12-08
17050	ORIG	2010-09-07
7009	ORIG	2010-09-02