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 2 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefFLUTICASONE PROPIONATEP & L Development, LLCf83fabaa-1c6c-4a19-9f30-2f06df6d48f42026-05-26WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Mucinex Nasal Congestion and Allergy ReliefFLUTICASONE PROPIONATEReckitt Benckiser LLC47d8bb65-0bff-f24d-e063-6394a90affaf2026-05-20WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Equate Childrens Allergy ReliefFLUTICASONE PROPIONATEWALMART INC.7e6949aa-66a7-4288-9990-3ad2ece1df3d2026-05-19WarningsName fallback
generic name: FLUTICASONE PROPIONATE
XHANCEFLUTICASONE PROPIONATEParatek Pharmaceuticals, Inc.44fcea33-8cfa-3a5c-e063-6394a90aafb22026-05-19Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEA-S Medication Solutionsda4e897e-9be1-499a-8889-15398b30ef3b2026-05-14Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEGLENMARK THERAPEUTICS INC., USA5494106f-6792-409e-b63f-b63b981409592026-05-05WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healthf4b9fcfc-f3f7-4ce0-8f97-3d475081aa672026-04-29WarningsName fallback
generic name: FLUTICASONE PROPIONATE
childrens allergy reliefFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4b1d223a-723b-4569-9505-da727691bc562026-04-29WarningsName fallback
generic name: FLUTICASONE PROPIONATE
CareOne Allergy ReliefFLUTICASONE PROPIONATEAmerican Sales Company587d7c72-a70e-4ada-945d-14989b96350c2026-04-23WarningsName fallback
generic name: FLUTICASONE PROPIONATE
careone childrens allergy reliefFLUTICASONE PROPIONATEAmerican Sales Company45ffaf45-8b88-44ba-804b-c2b5635898982026-04-23WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEPreferred Pharmaceuticals Inc.0a3447a1-407c-40a8-99bb-7e9a86eb37df2026-04-22Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEPreferred Pharmaceuticals, Inc.4916301d-bcc8-4cd1-86b4-7bf0aecfbf682026-04-22Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Up and Up Allergy Relief NasalFLUTICASONE PROPIONATETarget Corporation51c0a953-93cb-4d0a-b51c-02d9482d17462026-04-20WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company783ce1b9-27e4-428a-9f5e-04e70b234ac92026-04-09WarningsName fallback
generic name: FLUTICASONE PROPIONATE
allergy reliefFLUTICASONE PROPIONATESafeway7b5547e1-af4d-4ba9-bd92-524aa11a0ecf2026-04-01WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEGlenmark Pharmaceuticals Inc., USA27a9b531-f0fd-44ee-b197-ac4b7d64b30c2026-03-25Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate spray, meteredFLUTICASONE PROPIONATEChartwell RX, LLC71a2609f-c4b9-49b0-8185-83c20c22e1d62026-03-20Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEDirect_RX8b9f7474-8d89-b3e6-e053-2995a90aeddb2026-03-17Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEGrocery Outlet838bbb29-0aa3-4c88-a10d-81be71c202112026-03-16WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEIPG Pharmaceuticals, Inc.f1965bd9-1851-4be5-bbe0-71dd59e034d52026-03-16Warnings, Adverse reactionsName 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