Home Applications 208024 Application 208024
Type ANDA
Sponsor HI TECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE SPRAY, METERED;NASAL 0.05MG/SPRAY No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208024-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17
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 2 · 43 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 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208024-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2019-04-17 f41ea6bd6efb…
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 5 of 7 · 128 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluticasone Propionate FLUTICASONE PROPIONATE TWIN MED LLC 9337aa4b-382d-4ab9-b312-60417cdd40cf 2025-05-01 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Asclemed USA, Inc. 6e2d11f9-94d8-4434-b46b-8e2fcc9276fb 2025-04-19 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE childrens allergy relief FLUTICASONE PROPIONATE Safeway 44b980b1-660b-4064-8415-87c0c69e48ff 2025-03-26 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Good Sense 24 hour allergy nasal FLUTICASONE PROPIONATE RedPharm Drug, Inc f4c26992-c988-e20f-e053-2a95a90afb65 2025-01-23 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Asclemed USA, Inc. 504397c5-6f9f-45cc-9cc9-997da0a80364 2025-01-15 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE Haleon US Holdings LLC b6134ba0-b70a-4eac-9a82-cef64b242c1d 2024-12-19 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Quality Care Products, LLC 1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e 2024-12-18 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE allergy nasal FLUTICASONE PROPIONATE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 2aee623c-602a-407c-b7a3-e29928d7dfed 2024-12-18 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE A-S Medication Solutions 3b1849e1-bd0b-42e4-a4ac-f156dc18604a 2024-11-06 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE A-S Medication Solutions faaa1436-dafb-4f65-b062-b51b902f43c5 2024-10-29 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Proficient Rx LP 1d5d5f27-6565-4e7b-9923-faa3d15cb1c4 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Proficient Rx LP ab8c172b-c369-4372-95f9-dd1a28b3982b 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone FLUTICASONE PROPIONATE NuCare Pharmaceuticals,Inc. 549ff4f2-fa68-3dd8-e054-00144ff8d46c 2024-07-15 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE NuCare Pharmaceuticals,Inc. 8761a5e1-a9cb-0622-e053-2a95a90a3504 2024-06-14 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE CHILDRENS ALLERGY FLUTICASONE PROPIONATE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED b9b3efe4-2f5c-4d22-80a4-d15fb266fb23 2024-06-12 Warnings Name fallback generic name: FLUTICASONE PROPIONATE fluticasone propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd c4d361d4-d480-4fb2-8cc7-4cc3e57838dc 2024-05-01 Warnings, Adverse reactions Name fallback brand name: fluticasone propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Allegiant Health 4250d331-17b0-46be-a779-fb4f09bade16 2024-04-11 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 96e0681d-3788-49cc-8c0e-3185675b8da1 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack aed4ac53-cf6e-489e-bb7e-b8c444e4339e 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack f6aca9a9-0310-4c11-84b2-eacd19c45a1d 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0536-1373 Allergy Relief fluticasone propionate Rugby Laboratories, Inc. ANDA Current 50383-968 Fluticasone propionate Fluticasone propionate Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-968 Fluticasone propionate Fluticasone propionate Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-968 Fluticasone propionate Fluticasone propionate Akorn ANDA Current 50383-968 Fluticasone propionate Fluticasone propionate Hi-Tech Pharmacal Co., Inc. ANDA Current