Application 208798

Type
NDA
Sponsor
TEVA PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.055MG/INHYesNo
002ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.113MG/INHYesNo
003ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.232MG/INHYesNo
004ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.055MG/INHYesNo
005ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.113MG/INHYesNo
006ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.232MG/INHYesYes
007ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.03MG/INHYesNo
008ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.03MG/INHYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208798-001ARMONAIR RESPICLICKFLUTICASONE PROPIONATE0.055MG/INHPOWDER / INHALATIONRLD2017-01-27
N208798-002ARMONAIR RESPICLICKFLUTICASONE PROPIONATE0.113MG/INHPOWDER / INHALATIONRLD2017-01-27
N208798-003ARMONAIR RESPICLICKFLUTICASONE PROPIONATE0.232MG/INHPOWDER / INHALATIONRLD2017-01-27
N208798-004ARMONAIR DIGIHALERFLUTICASONE PROPIONATE0.055MG/INHPOWDER / INHALATIONRLD2020-02-20
N208798-005ARMONAIR DIGIHALERFLUTICASONE PROPIONATE0.113MG/INHPOWDER / INHALATIONRLD2020-02-20
N208798-006ARMONAIR DIGIHALERFLUTICASONE PROPIONATE0.232MG/INHPOWDER / INHALATIONRLD2020-02-20
N208798-007ARMONAIR RESPICLICKFLUTICASONE PROPIONATE0.03MG/INHPOWDER / INHALATIONRLD2021-07-09
N208798-008ARMONAIR DIGIHALERFLUTICASONE PROPIONATE0.03MG/INHPOWDER / INHALATIONRLD2022-04-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208798-001101953752031-02-14Drug product2019-03-05
N208798-00110195375*PED2031-08-14Pediatric extension
N208798-001119695442039-08-20Drug product2024-05-29
N208798-00111969544*PED2040-02-20Pediatric extension
N208798-002101953752031-02-14Drug product2019-03-05
N208798-00210195375*PED2031-08-14Pediatric extension
N208798-002119695442039-08-20Drug product2024-05-29
N208798-00211969544*PED2040-02-20Pediatric extension
N208798-003101953752031-02-14Drug product2019-03-05
N208798-00310195375*PED2031-08-14Pediatric extension
N208798-003119695442039-08-20Drug product2024-05-29
N208798-00311969544*PED2040-02-20Pediatric extension
N208798-004101953752031-02-14Drug product2020-03-20
N208798-00410195375*PED2031-08-14Pediatric extension
N208798-004109188162035-12-14Drug product2021-03-18
N208798-00410918816*PED2036-06-14Pediatric extension
N208798-004119695442039-08-20Drug product2024-05-29
N208798-004113446852039-09-26Drug product2022-06-29
N208798-00411969544*PED2040-02-20Pediatric extension
N208798-00411344685*PED2040-03-26Pediatric extension
N208798-004111732592040-07-06Drug product2021-12-08
N208798-00411173259*PED2041-01-06Pediatric extension
N208798-005101953752031-02-14Drug product2020-03-20
N208798-00510195375*PED2031-08-14Pediatric extension
N208798-005109188162035-12-14Drug product2021-03-18
N208798-00510918816*PED2036-06-14Pediatric extension
N208798-005119695442039-08-20Drug product2024-05-29
N208798-005113446852039-09-26Drug product2022-06-29
N208798-00511969544*PED2040-02-20Pediatric extension
N208798-00511344685*PED2040-03-26Pediatric extension
N208798-005111732592040-07-06Drug product2021-12-08
N208798-00511173259*PED2041-01-06Pediatric extension
N208798-006101953752031-02-14Drug product2020-03-20
N208798-00610195375*PED2031-08-14Pediatric extension
N208798-006109188162035-12-14Drug product2021-03-18
N208798-00610918816*PED2036-06-14Pediatric extension
N208798-006119695442039-08-20Drug product2024-05-29
N208798-006113446852039-09-26Drug product2022-06-29
N208798-00611969544*PED2040-02-20Pediatric extension
N208798-00611344685*PED2040-03-26Pediatric extension
N208798-006111732592040-07-06Drug product2021-12-08
N208798-00611173259*PED2041-01-06Pediatric extension
N208798-007101953752031-02-14Drug product2021-08-05
N208798-00710195375*PED2031-08-14Pediatric extension
N208798-007119695442039-08-20Drug product2024-05-29
N208798-00711969544*PED2040-02-20Pediatric extension
N208798-008101953752031-02-14Drug product2022-05-05
N208798-00810195375*PED2031-08-14Pediatric extension
N208798-008109188162035-12-14Drug product2022-05-05
N208798-00810918816*PED2036-06-14Pediatric extension
N208798-008119695442039-08-20Drug product2024-05-29
N208798-008113446852039-09-26Drug product2022-06-29
N208798-00811969544*PED2040-02-20Pediatric extension
N208798-00811344685*PED2040-03-26Pediatric extension
N208798-008111732592040-07-06Drug product2022-05-05
N208798-00811173259*PED2041-01-06Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208798-001ARMONAIR RESPICLICK0.055MG/INHPOWDER / INHALATIONRLD2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N208798-002ARMONAIR RESPICLICK0.113MG/INHPOWDER / INHALATIONRLD2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N208798-003ARMONAIR RESPICLICK0.232MG/INHPOWDER / INHALATIONRLD2017-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N208798-004ARMONAIR DIGIHALER0.055MG/INHPOWDER / INHALATIONRLD2020-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N208798-005ARMONAIR DIGIHALER0.113MG/INHPOWDER / INHALATIONRLD2020-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N208798-006ARMONAIR DIGIHALER0.232MG/INHPOWDER / INHALATIONRLD2020-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N208798-007ARMONAIR RESPICLICK0.03MG/INHPOWDER / INHALATIONRLD2021-07-0984e616aacf4f…
2026-09-14 22:38:342026-08N208798-008ARMONAIR DIGIHALER0.03MG/INHPOWDER / INHALATIONRLD2022-04-0884e616aacf4f…
2026-08-18 06:07:402026-07N208798-001ARMONAIR RESPICLICK0.055MG/INHPOWDER / INHALATIONRLD2017-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-002ARMONAIR RESPICLICK0.113MG/INHPOWDER / INHALATIONRLD2017-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-003ARMONAIR RESPICLICK0.232MG/INHPOWDER / INHALATIONRLD2017-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-004ARMONAIR DIGIHALER0.055MG/INHPOWDER / INHALATIONRLD2020-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-005ARMONAIR DIGIHALER0.113MG/INHPOWDER / INHALATIONRLD2020-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-006ARMONAIR DIGIHALER0.232MG/INHPOWDER / INHALATIONRLD2020-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-007ARMONAIR RESPICLICK0.03MG/INHPOWDER / INHALATIONRLD2021-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208798-008ARMONAIR DIGIHALER0.03MG/INHPOWDER / INHALATIONRLD2022-04-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208798-001ARMONAIR RESPICLICK0.055MG/INHPOWDER / INHALATIONRLD2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-002ARMONAIR RESPICLICK0.113MG/INHPOWDER / INHALATIONRLD2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-003ARMONAIR RESPICLICK0.232MG/INHPOWDER / INHALATIONRLD2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-004ARMONAIR DIGIHALER0.055MG/INHPOWDER / INHALATIONRLD2020-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-005ARMONAIR DIGIHALER0.113MG/INHPOWDER / INHALATIONRLD2020-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-006ARMONAIR DIGIHALER0.232MG/INHPOWDER / INHALATIONRLD2020-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-007ARMONAIR RESPICLICK0.03MG/INHPOWDER / INHALATIONRLD2021-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208798-008ARMONAIR DIGIHALER0.03MG/INHPOWDER / INHALATIONRLD2022-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-001ARMONAIR RESPICLICK0.055MG/INHPOWDER / INHALATIONRLD2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-002ARMONAIR RESPICLICK0.113MG/INHPOWDER / INHALATIONRLD2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-003ARMONAIR RESPICLICK0.232MG/INHPOWDER / INHALATIONRLD2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-004ARMONAIR DIGIHALER0.055MG/INHPOWDER / INHALATIONRLD2020-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-005ARMONAIR DIGIHALER0.113MG/INHPOWDER / INHALATIONRLD2020-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-006ARMONAIR DIGIHALER0.232MG/INHPOWDER / INHALATIONRLD2020-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-007ARMONAIR RESPICLICK0.03MG/INHPOWDER / INHALATIONRLD2021-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-008ARMONAIR DIGIHALER0.03MG/INHPOWDER / INHALATIONRLD2022-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208798-001ARMONAIR RESPICLICK0.055MG/INHPOWDER / INHALATIONRLD2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-002ARMONAIR RESPICLICK0.113MG/INHPOWDER / INHALATIONRLD2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-003ARMONAIR RESPICLICK0.232MG/INHPOWDER / INHALATIONRLD2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-004ARMONAIR DIGIHALER0.055MG/INHPOWDER / INHALATIONRLD2020-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-005ARMONAIR DIGIHALER0.113MG/INHPOWDER / INHALATIONRLD2020-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-006ARMONAIR DIGIHALER0.232MG/INHPOWDER / INHALATIONRLD2020-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-007ARMONAIR RESPICLICK0.03MG/INHPOWDER / INHALATIONRLD2021-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-008ARMONAIR DIGIHALER0.03MG/INHPOWDER / INHALATIONRLD2022-04-086a471c1ec25d…

Observed Orange Book patent history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208798-001101953752031-02-14Drug product2019-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N208798-00110195375*PED2031-08-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-001119695442039-08-20Drug product2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-00111969544*PED2040-02-20Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-002101953752031-02-14Drug product2019-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N208798-00210195375*PED2031-08-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-002119695442039-08-20Drug product2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-00211969544*PED2040-02-20Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-003101953752031-02-14Drug product2019-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N208798-00310195375*PED2031-08-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-003119695442039-08-20Drug product2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-00311969544*PED2040-02-20Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-004101953752031-02-14Drug product2020-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N208798-00410195375*PED2031-08-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-004109188162035-12-14Drug product2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N208798-00410918816*PED2036-06-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-004119695442039-08-20Drug product2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-004113446852039-09-26Drug product2022-06-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-00411969544*PED2040-02-20Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-00411344685*PED2040-03-26Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-004111732592040-07-06Drug product2021-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N208798-00411173259*PED2041-01-06Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-005101953752031-02-14Drug product2020-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N208798-00510195375*PED2031-08-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-005109188162035-12-14Drug product2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N208798-00510918816*PED2036-06-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-005119695442039-08-20Drug product2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-005113446852039-09-26Drug product2022-06-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-00511969544*PED2040-02-20Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-00511344685*PED2040-03-26Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-005111732592040-07-06Drug product2021-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N208798-00511173259*PED2041-01-06Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-006101953752031-02-14Drug product2020-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N208798-00610195375*PED2031-08-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-006109188162035-12-14Drug product2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N208798-00610918816*PED2036-06-14Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-006119695442039-08-20Drug product2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-006113446852039-09-26Drug product2022-06-2984e616aacf4f…
2026-09-14 22:38:342026-08N208798-00611969544*PED2040-02-20Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208798-00611344685*PED2040-03-26Pediatric extension84e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-001NPP2024-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-001PED2025-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-004NPP2024-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-004PED2025-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-007NS2024-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208798-007PED2025-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N208798-001NPP2024-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-001PED2025-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-004NPP2024-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-004PED2025-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-007NS2024-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208798-007PED2025-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208798-001NPP2024-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208798-001PED2025-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208798-004NPP2024-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208798-004PED2025-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208798-007NS2024-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208798-007PED2025-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208798-001NPP2024-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208798-001PED2025-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208798-004NPP2024-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208798-004PED2025-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208798-007NS2024-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208798-007PED2025-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208798-001NPP2024-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208798-001PED2025-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208798-004NPP2024-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208798-004PED2025-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208798-007NS2024-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208798-007PED2025-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208798-001NPP2024-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208798-001PED2025-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208798-004NPP2024-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208798-004PED2025-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208798-007NS2024-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208798-007PED2025-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208798-001NPP2024-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208798-001PED2025-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208798-004NPP2024-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208798-004PED2025-01-095bbf6a4d5a75…

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 6 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCfab7a1f4-75e0-416f-9644-07aff08e6ab02024-03-05WarningsName fallback
generic name: FLUTICASONE PROPIONATE
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLC3adff80f-fca7-4cc5-b106-0f68f71c85b02024-02-08WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEA-S Medication Solutions64d669da-559c-40f5-b649-2ce164c211ea2024-01-30Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutions4a4b7242-1083-4912-a318-25c3914aaf222024-01-11Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUSFLUTICASONE PROPIONATEA-S Medication Solutions038e6c40-9421-40ef-874b-8f4d7110a74a2024-01-11Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFAFLUTICASONE PROPIONATEA-S Medication Solutions674b1c81-359d-4fc4-8ce6-a53931b171e02024-01-02Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
FLOVENT HFAFLUTICASONE PROPIONATEA-S Medication Solutions74563f7b-8512-4b76-8c55-b88b9cd3206b2023-12-09Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltd16985600-3f81-4d51-8bf7-0cbbd89856a12023-11-30Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healtha4e1c265-5205-4089-8190-0755ede838962023-11-28WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATECosette Pharmaceuticals, Inc.e7ef2aaf-749c-66c9-2bdf-7214ab00060e2023-11-22Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFAFLUTICASONE PROPIONATEA-S Medication Solutions4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d2023-11-17Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFAFLUTICASONE PROPIONATEPrasco Laboratories99249b31-bf0a-464f-8335-845279350dbe2023-09-28Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack8bd6f3a4-87f7-449e-8fcc-fec1537fcab32023-07-17Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack0120296b-bebc-4a2d-8058-6caf41f96e522023-07-17Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEPrasco Laboratories44d009ba-d4b8-410f-b2bc-71ab2d05ac9e2023-05-31Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutionse2df3810-3b92-4678-8f62-683c656b1de92023-04-16Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltd78e056e2-d39e-4d20-9ab2-332bd69736192022-12-30Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Welby FluticasoneFLUTICASONE PROPIONATEAldi Inc446bfcd9-8f28-4a96-840f-c72ac59704082022-11-03WarningsName fallback
generic name: FLUTICASONE PROPIONATE
topcare fluticasone propionate nasalFLUTICASONE PROPIONATETopco Associates LLCf7c425d2-4afb-478f-83bc-eb336910233b2022-11-01WarningsName fallback
generic name: FLUTICASONE PROPIONATE
equate allergy reliefFLUTICASONE PROPIONATEWal-Mart Stores Inc959167e8-f4a1-49b9-b3a6-f0d0b3d7d4772022-10-14WarningsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59310-114ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-114ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-114ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-200ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-200ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-200ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-311ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-311ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-311ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-505ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-505ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-505ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-515ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-515ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-515ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-525ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-525ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-525ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-705ArmonAir RespiClickFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-711ArmonAir RespiClickFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-722ArmonAir RespiClickFluticasone PropionateTeva Respiratory, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76631SUPPL 2023-11-20
76623SUPPL 2023-11-17
70748SUPPL2022-04-11
70741SUPPL2022-04-11
68060SUPPL2021-07-13
68047SUPPL2021-07-12
64628SUPPL2020-09-21
64621SUPPL2020-09-21
53013SUPPL2018-03-15
52821SUPPL2018-03-06
48046ORIG2017-04-14
47041ORIG2017-01-31
47034ORIG2017-01-27
51124ORIG1900-01-01
51123ORIG1900-01-01
51122ORIG1900-01-01