Home Applications 208798 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 TE codes 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.
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 Product TE source text 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 Use code 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.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 7 · 127 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluticasone FLUTICASONE PROPIONATE YYBA CORP 535b2575-8af8-d951-e063-6394a90ac72d 2026-09-01 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Glenmark Pharmaceuticals Inc., USA bc08915f-fa3a-4509-a01c-42b577f39b99 2026-08-19 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Walgreens 16756136-e813-8a91-3351-7e759d1b4b94 2026-08-17 Warnings Name fallback generic name: FLUTICASONE PROPIONATE TopCare Childrens Allergy Relief Nasal 24 Hour FLUTICASONE PROPIONATE Topco Associates LLC 3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a9 2026-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE CHILDRENS ALLERGY RELIEF FLUTICASONE PROPIONATE Walgreen Company 2e81a611-15c2-466e-a111-8ecf939b9560 2026-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Good Sense 24 hour allergy nasal FLUTICASONE PROPIONATE L. Perrigo Company 6f3f64e6-d1f8-40d7-bb25-f6f279db9987 2026-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Equate Allergy Relief FLUTICASONE PROPIONATE WALMART INC. bc824143-b876-4c3d-86fd-81fb58673851 2026-08-10 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Golden State Medical Supply, Inc. 534d78c5-4ba0-4ab1-e063-6294a90a8ff7 2026-08-05 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE ALLERGY RELIEF NASAL FLUTICASONE PROPIONATE Amazon.com Services LLC dc552613-5cfe-4de3-b2c0-79703316758a 2026-07-30 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE The Kroger Co. f05689fa-7ff3-0846-c647-bdbe79cb2ff8 2026-07-29 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE DISKUS FLUTICASONE PROPIONATE Sportpharm LLC 348cbd8c-edeb-499c-961d-3aeb5cc2cef1 2026-07-28 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE P & L Development, LLC e3347976-facd-49b6-9ae1-7ed3cd02ba96 2026-07-02 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Chain Drug Marketing Association, Inc. 0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc7 2026-07-02 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Childrens Fluticasone Propionate ALLERGY RELIEF FLUTICASONE PROPIONATE GLENMARK THERAPEUTICS INC., USA 9aaa30cf-1e3b-4382-91dc-568067a4b0ac 2026-06-30 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Family Dollar Stores, LLC 4dd65267-9905-4f45-e063-6294a90a2516 2026-06-17 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate ALLERGY RELIEF FLUTICASONE PROPIONATE YYBA CORP 5348075c-63ca-20f7-e063-6394a90a3f5c 2026-06-12 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Preferred Pharmaceuticals Inc. 8225d521-f1f7-4d21-9095-9a2e1833d1bf 2026-06-08 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE allergy relief nasal FLUTICASONE PROPIONATE HyVee Inc c3327be1-e4a9-4b02-968d-eff5e18cbc84 2026-06-03 Warnings Name fallback generic name: FLUTICASONE PROPIONATE allergy nasal FLUTICASONE PROPIONATE Rite Aid Corporation e471dacd-9b6e-4783-9a14-aa95d00cbc9c 2026-06-03 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE YYBA Corp 5333562e-9d8e-2618-e063-6394a90a8673 2026-06-01 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