Application 202236

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DYMISTA	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	SPRAY, METERED;NASAL	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	Yes	Yes

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
N202236-001	DYMISTA	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202236-001	AB

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
N202236-001	8168620	2026-02-24		Drug product	2012-05-11
N202236-001	8168620*PED	2026-08-24		Pediatric extension

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202236-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202236-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202236-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202236-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202236-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202236-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202236-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202236-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202236-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202236-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202236-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202236-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202236-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202236-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202236-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202236-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202236-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202236-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202236-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202236-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202236-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202236-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202236-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202236-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202236-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202236-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 309 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	9259428	2023-06-13	U-644		2016-03-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	9901585	2023-06-13		Drug product	2018-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	8163723	2023-08-29	U-644		2012-05-11	`5c6f7cd8ea54…`

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
Azelastine Hydrochloride and Fluticasone Propionate	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	Mylan Pharmaceuticals Inc.	7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e	2024-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202236 application number: NDA202236 ndc (product): 0378-3458
DYMISTA	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	Viatris Specialty LLC	4c557ec4-c4cf-11df-851a-0800200c9a66	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202236 application number: NDA202236 ndc (product): 0037-0245

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals	NDA	Current
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals	NDA	Current
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals	NDA	Current
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals Inc.	NDA	Current
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals	NDA	Current
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals	NDA	Current
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate	Meda Pharmaceuticals	NDA	Current
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
69621-812	Ticalast	azelastine hydrochloride and fluticasone propionate	Shoreline Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80616	SUPPL	2024-12-18
80608	SUPPL	2024-12-18
67114	SUPPL	2021-04-19
67100	SUPPL	2021-04-19
55434	SUPPL	2018-09-12
55409	SUPPL	2018-09-07
9994	SUPPL	2015-02-24
40142	SUPPL	2015-02-23
51256	SUPPL	2013-09-06
44849	ORIG	2013-05-06
43390	ORIG	2013-05-06
40141	SUPPL	2012-08-22
32212	SUPPL	2012-08-17
32211	ORIG	2012-05-03
40140	ORIG	2012-05-02
63507	ORIG	1900-01-01
63506	ORIG	1900-01-01
54096	ORIG	1900-01-01
51875	SUPPL	1900-01-01
51874	SUPPL	1900-01-01