Application 200925

Type: ANDA
Sponsor: AMRING PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LATANOPROST	LATANOPROST	SOLUTION/DROPS;OPHTHALMIC	0.005%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A200925-001	LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT		2011-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200925-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200925-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2011-03-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200925-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200925-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200925-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200925-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200925-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200925-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200925-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200925-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200925-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200925-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200925-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200925-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200925-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200925-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200925-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200925-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200925-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200925-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200925-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200925-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200925-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200925-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200925-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200925-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200925-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200925-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200925-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200925-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200925-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200925-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200925-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200925-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200925-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200925-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200925-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200925-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200925-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200925-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200925-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200925-001	AT	1	`e64feba35796…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LATANOPROST	LATANOPROST	NuCare Pharmaceuticals,Inc.	be74d517-7f73-a74c-e053-2a95a90a3819	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: LATANOPROST generic name: LATANOPROST
Latanoprost	LATANOPROST	Micro Labs Limited	298fc762-f4d4-47cb-a7a2-b5dc7f965c7f	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
LATANOPROST	LATANOPROST	Somerset Therapeutics, LLC	5d0b99ad-f05a-44c7-ac61-26b5a533ea8d	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: LATANOPROST generic name: LATANOPROST
XELPROS	LATANOPROST	Sun Pharmaceutical Industries, Inc.	34ad5cf6-4df0-4104-bddd-4c7631133ded	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: LATANOPROST
latanoprost	LATANOPROST	GLENMARK PHARMACEUTICALS INC	821d2ad5-a430-4fd2-8cfd-50b2118b8639	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	Bausch & Lomb Incorporated	68aaacbe-98c5-450b-9bf4-4809d7ad2ca0	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	NuCare Pharmaceuticals, Inc.	3c47a089-2c72-f58c-e063-6294a90a4cce	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	Sagent Pharmaceuticals	7474dc53-e5e5-44f2-9f56-b2cbacdc0c32	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	A-S Medication Solutions	5f1987e0-b0ce-47b2-998b-97453a7db5c3	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
latanoprost	LATANOPROST	Gland Pharma Limited	113abcc6-6e5c-4a57-ad6a-d69508ee990e	2024-11-29	Warnings, Adverse reactions	Name fallback brand name: latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	Proficient Rx LP	bfd773ed-c461-4732-b1ba-0c240f3fdae0	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	Aurobindo Pharma Limited	19cdfef0-b770-4758-8f59-1769e4b6119c	2024-09-27	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
Latanoprost	LATANOPROST	Mylan Pharmaceuticals Inc.	463ecfde-5acb-4983-969d-0c0021bfbf48	2024-09-15	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
LATANOPROST	LATANOPROST	Rising Pharma Holdings, Inc.	e25b82a9-1b04-4b40-8472-be107a2a6731	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: LATANOPROST generic name: LATANOPROST
Latanoprost	LATANOPROST	A-S Medication Solutions	8fb5edec-d94a-4aad-b42e-756267a3ae55	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST
XALATAN	LATANOPROST	Viatris Specialty LLC	a98595b3-9f47-48e0-b18d-550a2095f264	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: LATANOPROST
Latanoprost	LATANOPROST	Sandoz Inc	1fba56a6-c8dc-4f34-b05d-efdea75d2fea	2023-01-31	Warnings, Adverse reactions	Name fallback brand name: Latanoprost generic name: LATANOPROST

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0830	Latanoprost	Latanoprost	American Regent, Inc.	ANDA	Current