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 7 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	75049554-64ca-4efa-b8d1-13cf31d0ff90	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Cosette Pharmaceuticals, Inc.	14c8d082-b301-8f09-a509-950459ae0a28	2022-05-05	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Glenmark Pharmaceuticals Inc., USA	3c7b3482-e2fd-4857-9394-a47fd7f4c47b	2020-02-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Proficient Rx LP	96af29b8-16b4-4113-9ec3-338438e11a49	2019-11-01	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUS	FLUTICASONE PROPIONATE	Proficient Rx LP	816e929e-6ba0-437d-80bb-00068419ed53	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Selder, S.A. de C.V.	2da4ba91-c356-473d-b20c-5bb9265767df	2017-11-29	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4e1cd546-4598-115b-0357-5d0c22731faa	2017-11-17	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