Application 211746

Type: NDA
Sponsor: GLENMARK SPECIALTY SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYALTRIS	OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE MONOHYDRATE	SPRAY, METERED;NASAL	665MCG/25MCG	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
N211746-001	RYALTRIS	MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2022-01-13

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211746-001	10016443	2034-09-04	U-3297		2022-02-11
N211746-001	10376526	2034-09-04		Drug product	2022-02-11
N211746-001	10517880	2034-09-04	U-3297	Drug product	2022-02-11
N211746-001	10548907	2034-09-04	U-3297		2022-02-11
N211746-001	10561672	2034-09-04		Drug product	2022-02-11
N211746-001	10646500	2034-09-04	U-3297		2022-02-11
N211746-001	10758550	2034-09-04	U-3296		2022-02-11
N211746-001	10765686	2034-09-04	U-3295		2022-02-11
N211746-001	11400101	2034-09-04	U-3297		2022-08-25
N211746-001	12064442	2034-09-04	U-3297		2024-09-12
N211746-001	9078923	2034-09-04	U-3297	Drug product	2022-02-11
N211746-001	9370483	2034-09-04		Drug product	2022-02-11
N211746-001	9750754	2034-09-04	U-3297	Drug product	2022-02-11
N211746-001	9937189	2034-09-04		Drug product	2022-02-11
N211746-001	11679210	2038-09-03		Drug product	2023-07-20
N211746-001	12303635	2039-04-08		Drug substance, Drug product	2025-06-06
N211746-001	12653833	2044-11-21	U-4564	Drug product	2026-07-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211746-001	NPP	2029-07-07

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.

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	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211746-001	RYALTRIS	0.025MG/SPRAY;0.665MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-01-13	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 450 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	N211746-001	10016443	2034-09-04	U-3297		2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10376526	2034-09-04		Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10517880	2034-09-04	U-3297	Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10548907	2034-09-04	U-3297		2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10561672	2034-09-04		Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10646500	2034-09-04	U-3297		2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10758550	2034-09-04	U-3296		2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	10765686	2034-09-04	U-3295		2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	11400101	2034-09-04	U-3297		2022-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	12064442	2034-09-04	U-3297		2024-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	9078923	2034-09-04	U-3297	Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	9370483	2034-09-04		Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	9750754	2034-09-04	U-3297	Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	9937189	2034-09-04		Drug product	2022-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	11679210	2038-09-03		Drug product	2023-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	12303635	2039-04-08		Drug substance, Drug product	2025-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211746-001	12653833	2044-11-21	U-4564	Drug product	2026-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10016443	2034-09-04	U-3297		2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10376526	2034-09-04		Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10517880	2034-09-04	U-3297	Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10548907	2034-09-04	U-3297		2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10561672	2034-09-04		Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10646500	2034-09-04	U-3297		2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10758550	2034-09-04	U-3296		2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	10765686	2034-09-04	U-3295		2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	11400101	2034-09-04	U-3297		2022-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	12064442	2034-09-04	U-3297		2024-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	9078923	2034-09-04	U-3297	Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	9370483	2034-09-04		Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	9750754	2034-09-04	U-3297	Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	9937189	2034-09-04		Drug product	2022-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	11679210	2038-09-03		Drug product	2023-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211746-001	12303635	2039-04-08		Drug substance, Drug product	2025-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10016443	2034-09-04	U-3297		2022-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10376526	2034-09-04		Drug product	2022-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10517880	2034-09-04	U-3297	Drug product	2022-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10548907	2034-09-04	U-3297		2022-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10561672	2034-09-04		Drug product	2022-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10646500	2034-09-04	U-3297		2022-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	10758550	2034-09-04	U-3296		2022-02-11	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211746-001	NPP	2029-07-07	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211746-001	NP	2025-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211746-001	NP	2025-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211746-001	NP	2025-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211746-001	NP	2025-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211746-001	NP	2025-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211746-001	NP	2025-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211746-001	NP	2025-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211746-001	NP	2025-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211746-001	NP	2025-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211746-001	NP	2025-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211746-001	NP	2025-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211746-001	NP	2025-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211746-001	NP	2025-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211746-001	NP	2025-01-13	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211746-001	NP	2025-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211746-001	NP	2025-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211746-001	NP	2025-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211746-001	NP	2025-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211746-001	NP	2025-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211746-001	NP	2025-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211746-001	NP	2025-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211746-001	NP	2025-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211746-001	NP	2025-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211746-001	NP	2025-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211746-001	NP	2025-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211746-001	NP	2025-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211746-001	NP	2025-01-13	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ryaltris	OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE	Glenmark Pharmaceuticals Inc., USA	406be932-f00e-4c66-9dd1-c142090fe822	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211746 application number: NDA211746
Ryaltris	OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE	HIKMA SPECIALTY USA INC.	382eac74-a7ce-4f42-ac0a-b253308f335f	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211746 application number: NDA211746 ndc (product): 59467-700

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
59467-700	Ryaltris	olopatadine hydrochloride and mometasone furoate	HIKMA SPECIALTY USA INC.	NDA	Current
59467-700	Ryaltris	olopatadine hydrochloride and mometasone furoate	HIKMA SPECIALTY USA INC.	NDA	Current
59467-700	Ryaltris	olopatadine hydrochloride and mometasone furoate	HIKMA SPECIALTY USA INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75328	SUPPL	2023-08-31
75319	SUPPL	2023-08-30
74622	SUPPL	2023-06-26
74621	SUPPL	2023-06-26
73138	ORIG	2023-01-10
72253	SUPPL	2022-10-05
72211	SUPPL	2022-10-03
69895	ORIG	2022-01-18
69893	ORIG	2022-01-18