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 6 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 Bryant Ranch Prepack 8204a0c2-bd24-409a-b848-b3b369df642f 2024-03-11 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE 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 brand name: Fluticasone Propionate 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 brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Allegiant Health a4e1c265-5205-4089-8190-0755ede83896 2023-11-28 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Cosette Pharmaceuticals, Inc. e7ef2aaf-749c-66c9-2bdf-7214ab00060e 2023-11-22 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate 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 brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 0120296b-bebc-4a2d-8058-6caf41f96e52 2023-07-17 Adverse reactions Name fallback brand name: Fluticasone Propionate 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 brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd 78e056e2-d39e-4d20-9ab2-332bd6973619 2022-12-30 Adverse reactions Name fallback brand name: Fluticasone Propionate 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
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