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 6 of 7 · 127 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHILDRENS FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE Haleon US Holdings LLC fab7a1f4-75e0-416f-9644-07aff08e6ab0 2024-03-05 Warnings Name fallback generic name: FLUTICASONE PROPIONATE CHILDRENS FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE Haleon US Holdings LLC 3adff80f-fca7-4cc5-b106-0f68f71c85b0 2024-02-08 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE DISKUS FLUTICASONE PROPIONATE A-S Medication Solutions 64d669da-559c-40f5-b649-2ce164c211ea 2024-01-30 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE A-S Medication Solutions 4a4b7242-1083-4912-a318-25c3914aaf22 2024-01-11 Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE FLOVENT DISKUS FLUTICASONE PROPIONATE A-S Medication Solutions 038e6c40-9421-40ef-874b-8f4d7110a74a 2024-01-11 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE A-S Medication Solutions 674b1c81-359d-4fc4-8ce6-a53931b171e0 2024-01-02 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE FLOVENT HFA FLUTICASONE PROPIONATE A-S Medication Solutions 74563f7b-8512-4b76-8c55-b88b9cd3206b 2023-12-09 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd 16985600-3f81-4d51-8bf7-0cbbd89856a1 2023-11-30 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Allegiant Health a4e1c265-5205-4089-8190-0755ede83896 2023-11-28 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Cosette Pharmaceuticals, Inc. e7ef2aaf-749c-66c9-2bdf-7214ab00060e 2023-11-22 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE A-S Medication Solutions 4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d 2023-11-17 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE Prasco Laboratories 99249b31-bf0a-464f-8335-845279350dbe 2023-09-28 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 8bd6f3a4-87f7-449e-8fcc-fec1537fcab3 2023-07-17 Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 0120296b-bebc-4a2d-8058-6caf41f96e52 2023-07-17 Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE DISKUS FLUTICASONE PROPIONATE Prasco Laboratories 44d009ba-d4b8-410f-b2bc-71ab2d05ac9e 2023-05-31 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE A-S Medication Solutions e2df3810-3b92-4678-8f62-683c656b1de9 2023-04-16 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd 78e056e2-d39e-4d20-9ab2-332bd6973619 2022-12-30 Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Welby Fluticasone FLUTICASONE PROPIONATE Aldi Inc 446bfcd9-8f28-4a96-840f-c72ac5970408 2022-11-03 Warnings Name fallback generic name: FLUTICASONE PROPIONATE topcare fluticasone propionate nasal FLUTICASONE PROPIONATE Topco Associates LLC f7c425d2-4afb-478f-83bc-eb336910233b 2022-11-01 Warnings Name fallback generic name: FLUTICASONE PROPIONATE equate allergy relief FLUTICASONE PROPIONATE Wal-Mart Stores Inc 959167e8-f4a1-49b9-b3a6-f0d0b3d7d477 2022-10-14 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