Application 206185

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XELPROS	LATANOPROST	EMULSION;OPHTHALMIC	0.005%	Yes	Yes

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
N206185-001	XELPROS	LATANOPROST	0.005%	EMULSION / OPHTHALMIC		RLD	2018-09-12

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206185-001	9539262	2028-10-15	U-2400		2018-09-25
N206185-001	9629852	2029-09-12		Drug product	2018-09-25

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD	2018-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206185-001	XELPROS	0.005%	EMULSION / OPHTHALMIC	RLD, RS	2018-09-12	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206185-001	9539262	2028-10-15	U-2400		2018-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206185-001	9629852	2029-09-12		Drug product	2018-09-25	`bb7c543d1eb4…`

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
XELPROS	LATANOPROST	Sun Pharmaceutical Industries, Inc.	34ad5cf6-4df0-4104-bddd-4c7631133ded	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206185 application number: NDA206185 ndc (product): 47335-317

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-317	XELPROS	latanoprost	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-317	XELPROS	latanoprost	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-317	XELPROS	latanoprost	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-317	XELPROS	latanprost	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-317	XELPROS	latanoprost	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-317	XELPROS	latanprost	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-317	XELPROS	latanoprost	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79856	SUPPL	2024-10-10
79854	SUPPL	2024-10-10
79853	SUPPL	2024-10-10
65746	SUPPL	2020-12-28
65708	SUPPL	2020-12-23
58867	ORIG	2019-05-28
55483	ORIG	2018-09-14
55482	ORIG	2018-09-14