Application 203051

Type: ANDA
Sponsor: HI TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIMATOPROST	BIMATOPROST	SOLUTION/DROPS;TOPICAL	0.03%	No	No

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
A203051-001	BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL			2018-10-09

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL		2018-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203051-001	BIMATOPROST	0.03%	SOLUTION/DROPS / TOPICAL	AT	2018-10-09	`cb3db0bc1861…`

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	A203051-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203051-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203051-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203051-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203051-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203051-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203051-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203051-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203051-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203051-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203051-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203051-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203051-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203051-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203051-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203051-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203051-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203051-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203051-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203051-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203051-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203051-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203051-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203051-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203051-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203051-001	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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bimatoprost	BIMATOPROST	First Nation Group, LLC	6a74ad65-dd76-45c1-9bbe-4218a9978b70	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Lifestar Pharma LLC	6ff31e11-fa48-4bfe-958c-47fedf21ce3d	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost 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 brand name: BIMATOPROST generic name: BIMATOPROST
bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Inc.	dfb6eabf-d8e0-4fd3-8ef6-c646da7a987d	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Inc.	a4f4ecb2-999f-4656-8f94-2f06c6dd7990	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Apotex Corp.	f5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c1	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Amneal Pharmaceuticals NY LLC	ea563519-3eae-4ac7-8234-173b0bd9a4f6	2025-05-24	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Somerset Therapeutics, LLC	b2afe664-49b0-4d69-bc89-adddf50b58ba	2025-03-22	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost 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 brand name: BIMATOPROST 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 generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	NuCare Pharmaceuticals,Inc.	147e2ec6-8fb1-ed5a-e063-6294a90a5eca	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Sandoz Inc	27bef7e1-750a-4ac1-ab5f-e4c0121ffcbc	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Limited	f471cb1d-57c7-4556-99af-68f8c96059fd	2023-08-25	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
bimatoprost	BIMATOPROST	Alembic Pharmaceuticals Limited	2b4107e4-c108-4ed5-b7e8-253b74f2ff25	2023-07-19	Warnings, Adverse reactions	Name fallback brand name: bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Aurobindo Pharma Limited	059a60ec-aee2-4c13-8307-05cd92e8729a	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Fosun Pharma USA Inc.	2f9ee30a-1737-44b2-8479-79a3ee88bf5b	2022-06-09	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST
Bimatoprost	BIMATOPROST	Gland Pharma Limited	2a4b5b6b-fc47-40d2-8396-ff60511a4cd1	2022-04-12	Warnings, Adverse reactions	Name fallback brand name: Bimatoprost generic name: BIMATOPROST

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-912	Bimatoprost	Bimatoprost	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Akorn	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Akorn	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Akorn	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-912	Bimatoprost	Bimatoprost	Hi-Tech Pharmacal Co., Inc.	ANDA	Current