Application 021275

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LUMIGAN	BIMATOPROST	SOLUTION/DROPS;OPHTHALMIC	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N021275-001	LUMIGAN	BIMATOPROST	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2001-03-16

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021275-001	LUMIGAN	0.03%	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021275-001	LUMIGAN	0.03%	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021275-001	LUMIGAN	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`f41ea6bd6efb…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bimatoprost	BIMATOPROST	Apotex Corp.	f5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c1	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	First Nation Group, LLC	6a74ad65-dd76-45c1-9bbe-4218a9978b70	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Lifestar Pharma LLC	6ff31e11-fa48-4bfe-958c-47fedf21ce3d	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
ZOLYMBUS	BIMATOPROST	Thea Pharma Inc.	f4504a0c-7998-4084-9e05-f999f1d051ed	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
BIMATOPROST	BIMATOPROST	NuCare Pharmaceuticals,Inc.	19b21ff7-847c-3dc9-e063-6394a90a20cc	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Inc.	dfb6eabf-d8e0-4fd3-8ef6-c646da7a987d	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Inc.	a4f4ecb2-999f-4656-8f94-2f06c6dd7990	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Amneal Pharmaceuticals NY LLC	ea563519-3eae-4ac7-8234-173b0bd9a4f6	2025-05-24	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Somerset Therapeutics, LLC	b2afe664-49b0-4d69-bc89-adddf50b58ba	2025-03-22	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
DURYSTA	BIMATOPROST	Allergan, Inc.	3f59da84-0bcc-4c84-b3e2-e215681ef341	2024-10-16	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
BIMATOPROST	BIMATOPROST	Micro Labs Limited	8c021e8a-2938-42a7-a17e-2f7f97256344	2024-09-26	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
LATISSE	BIMATOPROST	Allergan, Inc.	34f83d9d-2c64-463e-8a90-9a460fedfead	2024-07-01	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
LUMIGAN	BIMATOPROST	Allergan, Inc.	a5e67c75-db88-4372-bb07-c8dd15c97631	2024-06-22	Warnings, Adverse reactions	Name fallback brand name: LUMIGAN generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	NuCare Pharmaceuticals,Inc.	147e2ec6-8fb1-ed5a-e063-6294a90a5eca	2024-03-25	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Sandoz Inc	27bef7e1-750a-4ac1-ab5f-e4c0121ffcbc	2023-08-31	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Limited	f471cb1d-57c7-4556-99af-68f8c96059fd	2023-08-25	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Limited	2b4107e4-c108-4ed5-b7e8-253b74f2ff25	2023-07-19	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Aurobindo Pharma Limited	059a60ec-aee2-4c13-8307-05cd92e8729a	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Fosun Pharma USA Inc.	2f9ee30a-1737-44b2-8479-79a3ee88bf5b	2022-06-09	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Gland Pharma Limited	2a4b5b6b-fc47-40d2-8396-ff60511a4cd1	2022-04-12	Warnings, Adverse reactions	Name fallback generic name: BIMATOPROST

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70486	SUPPL	2022-03-11
70442	SUPPL	2022-03-09
64934	SUPPL	2020-10-16
64927	SUPPL	2020-10-16
49195	SUPPL	2017-08-02
49169	SUPPL	2017-08-01
27318	SUPPL	2014-10-02
14833	SUPPL	2014-09-30
4861	SUPPL	2012-03-19
36536	SUPPL	2012-03-16
14830	SUPPL	2011-03-11
36535	SUPPL	2011-02-08
42070	SUPPL	2008-07-30
27316	SUPPL	2006-06-28
14831	SUPPL	2006-06-28
27313	ORIG	2004-06-08
36534	SUPPL	2003-12-02
14832	SUPPL	2003-12-02
27317	SUPPL	2003-11-25
4860	SUPPL	2003-11-25
36533	SUPPL	2003-08-28
27315	SUPPL	2003-08-28
14829	SUPPL	2003-08-28
4859	SUPPL	2003-08-28
27314	SUPPL	2002-08-26
14828	SUPPL	2002-08-26
42069	ORIG	2001-08-20
14827	ORIG	2001-03-16