Application 208798

Type: NDA
Sponsor: TEVA PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.055MG/INH	Yes	No
002	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.113MG/INH	Yes	No
003	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.232MG/INH	Yes	No
004	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.055MG/INH	Yes	No
005	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.113MG/INH	Yes	No
006	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.232MG/INH	Yes	Yes
007	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.03MG/INH	Yes	No
008	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.03MG/INH	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208798-001	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27
N208798-002	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27
N208798-003	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27
N208798-004	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20
N208798-005	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20
N208798-006	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20
N208798-007	ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09
N208798-008	ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08

Orange Book patents#

Current patent rows page 1 of 1 · 56 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N208798-001	10195375	2031-02-14	Drug product	2019-03-05
N208798-001	10195375*PED	2031-08-14	Pediatric extension
N208798-001	11969544	2039-08-20	Drug product	2024-05-29
N208798-001	11969544*PED	2040-02-20	Pediatric extension
N208798-002	10195375	2031-02-14	Drug product	2019-03-05
N208798-002	10195375*PED	2031-08-14	Pediatric extension
N208798-002	11969544	2039-08-20	Drug product	2024-05-29
N208798-002	11969544*PED	2040-02-20	Pediatric extension
N208798-003	10195375	2031-02-14	Drug product	2019-03-05
N208798-003	10195375*PED	2031-08-14	Pediatric extension
N208798-003	11969544	2039-08-20	Drug product	2024-05-29
N208798-003	11969544*PED	2040-02-20	Pediatric extension
N208798-004	10195375	2031-02-14	Drug product	2020-03-20
N208798-004	10195375*PED	2031-08-14	Pediatric extension
N208798-004	10918816	2035-12-14	Drug product	2021-03-18
N208798-004	10918816*PED	2036-06-14	Pediatric extension
N208798-004	11969544	2039-08-20	Drug product	2024-05-29
N208798-004	11344685	2039-09-26	Drug product	2022-06-29
N208798-004	11969544*PED	2040-02-20	Pediatric extension
N208798-004	11344685*PED	2040-03-26	Pediatric extension
N208798-004	11173259	2040-07-06	Drug product	2021-12-08
N208798-004	11173259*PED	2041-01-06	Pediatric extension
N208798-005	10195375	2031-02-14	Drug product	2020-03-20
N208798-005	10195375*PED	2031-08-14	Pediatric extension
N208798-005	10918816	2035-12-14	Drug product	2021-03-18
N208798-005	10918816*PED	2036-06-14	Pediatric extension
N208798-005	11969544	2039-08-20	Drug product	2024-05-29
N208798-005	11344685	2039-09-26	Drug product	2022-06-29
N208798-005	11969544*PED	2040-02-20	Pediatric extension
N208798-005	11344685*PED	2040-03-26	Pediatric extension
N208798-005	11173259	2040-07-06	Drug product	2021-12-08
N208798-005	11173259*PED	2041-01-06	Pediatric extension
N208798-006	10195375	2031-02-14	Drug product	2020-03-20
N208798-006	10195375*PED	2031-08-14	Pediatric extension
N208798-006	10918816	2035-12-14	Drug product	2021-03-18
N208798-006	10918816*PED	2036-06-14	Pediatric extension
N208798-006	11969544	2039-08-20	Drug product	2024-05-29
N208798-006	11344685	2039-09-26	Drug product	2022-06-29
N208798-006	11969544*PED	2040-02-20	Pediatric extension
N208798-006	11344685*PED	2040-03-26	Pediatric extension
N208798-006	11173259	2040-07-06	Drug product	2021-12-08
N208798-006	11173259*PED	2041-01-06	Pediatric extension
N208798-007	10195375	2031-02-14	Drug product	2021-08-05
N208798-007	10195375*PED	2031-08-14	Pediatric extension
N208798-007	11969544	2039-08-20	Drug product	2024-05-29
N208798-007	11969544*PED	2040-02-20	Pediatric extension
N208798-008	10195375	2031-02-14	Drug product	2022-05-05
N208798-008	10195375*PED	2031-08-14	Pediatric extension
N208798-008	10918816	2035-12-14	Drug product	2022-05-05
N208798-008	10918816*PED	2036-06-14	Pediatric extension
N208798-008	11969544	2039-08-20	Drug product	2024-05-29
N208798-008	11344685	2039-09-26	Drug product	2022-06-29
N208798-008	11969544*PED	2040-02-20	Pediatric extension
N208798-008	11344685*PED	2040-03-26	Pediatric extension
N208798-008	11173259	2040-07-06	Drug product	2022-05-05
N208798-008	11173259*PED	2041-01-06	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 8 · 312 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208798-001	ARMONAIR RESPICLICK	0.055MG/INH	POWDER / INHALATION	RLD	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-002	ARMONAIR RESPICLICK	0.113MG/INH	POWDER / INHALATION	RLD	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-003	ARMONAIR RESPICLICK	0.232MG/INH	POWDER / INHALATION	RLD	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-004	ARMONAIR DIGIHALER	0.055MG/INH	POWDER / INHALATION	RLD	2020-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-005	ARMONAIR DIGIHALER	0.113MG/INH	POWDER / INHALATION	RLD	2020-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-006	ARMONAIR DIGIHALER	0.232MG/INH	POWDER / INHALATION	RLD	2020-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-007	ARMONAIR RESPICLICK	0.03MG/INH	POWDER / INHALATION	RLD	2021-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-008	ARMONAIR DIGIHALER	0.03MG/INH	POWDER / INHALATION	RLD	2022-04-08	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 239 · 9,521 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208798-001	10195375	2031-02-14	Drug product	2019-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-001	10195375*PED	2031-08-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-001	11969544	2039-08-20	Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-001	11969544*PED	2040-02-20	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-002	10195375	2031-02-14	Drug product	2019-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-002	10195375*PED	2031-08-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-002	11969544	2039-08-20	Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-002	11969544*PED	2040-02-20	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-003	10195375	2031-02-14	Drug product	2019-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-003	10195375*PED	2031-08-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-003	11969544	2039-08-20	Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-003	11969544*PED	2040-02-20	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	10195375	2031-02-14	Drug product	2020-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	10195375*PED	2031-08-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	10918816	2035-12-14	Drug product	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	10918816*PED	2036-06-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	11969544	2039-08-20	Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	11344685	2039-09-26	Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	11969544*PED	2040-02-20	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	11344685*PED	2040-03-26	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	11173259	2040-07-06	Drug product	2021-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-004	11173259*PED	2041-01-06	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	10195375	2031-02-14	Drug product	2020-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	10195375*PED	2031-08-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	10918816	2035-12-14	Drug product	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	10918816*PED	2036-06-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	11969544	2039-08-20	Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	11344685	2039-09-26	Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	11969544*PED	2040-02-20	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	11344685*PED	2040-03-26	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	11173259	2040-07-06	Drug product	2021-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-005	11173259*PED	2041-01-06	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	10195375	2031-02-14	Drug product	2020-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	10195375*PED	2031-08-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	10918816	2035-12-14	Drug product	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	10918816*PED	2036-06-14	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	11969544	2039-08-20	Drug product	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	11344685	2039-09-26	Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	11969544*PED	2040-02-20	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208798-006	11344685*PED	2040-03-26	Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-001	NPP	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-001	PED	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-004	NPP	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-004	PED	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-007	NS	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208798-007	PED	2025-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208798-001	NPP	2024-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-001	PED	2025-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-004	NPP	2024-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-004	PED	2025-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-007	NS	2024-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208798-007	PED	2025-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208798-001	NPP	2024-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208798-001	PED	2025-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208798-004	NPP	2024-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208798-004	PED	2025-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208798-007	NS	2024-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208798-007	PED	2025-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208798-001	NPP	2024-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208798-001	PED	2025-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208798-004	NPP	2024-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208798-004	PED	2025-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208798-007	NS	2024-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208798-007	PED	2025-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208798-001	NPP	2024-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208798-001	PED	2025-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208798-004	NPP	2024-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208798-004	PED	2025-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208798-007	NS	2024-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208798-007	PED	2025-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208798-001	NPP	2024-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208798-001	PED	2025-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208798-004	NPP	2024-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208798-004	PED	2025-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208798-007	NS	2024-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208798-007	PED	2025-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208798-001	NPP	2024-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208798-001	PED	2025-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208798-004	NPP	2024-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208798-004	PED	2025-01-09	`5bbf6a4d5a75…`

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 3 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nasopro 24	FLUTICASONE PROPIONATE	H E B	8416eb8f-e7fc-4cae-9aa1-84b2321ad67e	2026-03-10	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	e3c861e3-2507-9758-fcd0-8e82d721b5b4	2026-03-06	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	A-S Medication Solutions	0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c	2026-02-24	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Topcare Allergy Relief Nasal	FLUTICASONE PROPIONATE	Topco Associates LLC	4586256c-cc86-4792-92ef-5a65a35d6377	2026-02-19	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
ALLERGY RELIEF	FLUTICASONE PROPIONATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	1a4f4449-a8d3-4c5b-8ba1-21223574545b	2026-02-17	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	ASCLEMED USA INC.	e38d8796-b08c-49a8-94b8-0c2fdeb52a81	2026-02-10	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
exchange select allergy relief	FLUTICASONE PROPIONATE	Army & Air Force Exchange Service	f15d5c04-e308-4540-8c0a-d66a44c3d4fd	2026-02-10	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	Sportpharm LLC	95765842-415e-438b-8105-f6d93cddbdd0	2026-02-09	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
24 Hour Allergy Nasal	FLUTICASONE PROPIONATE	Walgreen Company	7698b73f-16f4-4b99-a3be-9453e8c35469	2026-02-05	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Advagen Pharma Ltd	2c1c465c-d008-470e-aa48-8b44bd60751c	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
365 WHOLE FOODS MARKET FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Whole Foods Market, Inc.	313517bd-cb08-49a5-8ef1-e5522cc21c80	2026-01-22	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
leader fluticasone propionate	FLUTICASONE PROPIONATE	Cardinal Health 110, LLC. dba Leader	14bb5d74-0384-417e-a06b-8868d85234dd	2026-01-21	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
DG Health Allergy Relief Nasal	FLUTICASONE PROPIONATE	Dolgencorp Inc	5f0514bd-7893-4602-a17b-716fb9947572	2026-01-21	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Foster and Thrive Allergy Relief	FLUTICASONE PROPIONATE	Strategic Sourcing Services LLC	67899c15-e5e5-4fe6-a639-71832969a761	2026-01-21	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	ff1cf174-ae6f-45f0-a081-26a34e55f9ea	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals, Inc.	4849c4e5-58ea-972c-e063-6394a90a809c	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
XHANCE	FLUTICASONE PROPIONATE	OptiNose US, Inc.	c79bbb9f-e483-4093-8c92-ea978e7bf278	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
allergy relief nasal	FLUTICASONE PROPIONATE	Publix Super Markets Inc	a70e26c8-2f50-49ac-8278-fc06e4c63e6a	2026-01-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	Rugby Laboratories	5227df05-f2c2-4bc4-91ee-da0fd03d1095	2026-01-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
good neighbor pharmacy fluticasone propionate	FLUTICASONE PROPIONATE	Amerisource Bergen	b12ddc59-b689-48ac-9a40-2b9ae04a1312	2026-01-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59310-114	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-114	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-114	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-200	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-200	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-200	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-311	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-311	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-311	ArmonAir Digihaler	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-505	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-505	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-505	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-515	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-515	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-515	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-525	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-525	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-525	ArmonAir Digihaler	fluticasone propionate	Teva Respiratory, LLC	NDA	Current
59310-705	ArmonAir RespiClick	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-711	ArmonAir RespiClick	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current
59310-722	ArmonAir RespiClick	Fluticasone Propionate	Teva Respiratory, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76631	SUPPL	2023-11-20
76623	SUPPL	2023-11-17
70748	SUPPL	2022-04-11
70741	SUPPL	2022-04-11
68060	SUPPL	2021-07-13
68047	SUPPL	2021-07-12
64628	SUPPL	2020-09-21
64621	SUPPL	2020-09-21
53013	SUPPL	2018-03-15
52821	SUPPL	2018-03-06
48046	ORIG	2017-04-14
47041	ORIG	2017-01-31
47034	ORIG	2017-01-27
51124	ORIG	1900-01-01
51123	ORIG	1900-01-01
51122	ORIG	1900-01-01