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	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 7 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate allergy relief	FLUTICASONE PROPIONATE	Wal-Mart Stores Inc	959167e8-f4a1-49b9-b3a6-f0d0b3d7d477	2022-10-14	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	75049554-64ca-4efa-b8d1-13cf31d0ff90	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Cosette Pharmaceuticals, Inc.	14c8d082-b301-8f09-a509-950459ae0a28	2022-05-05	Adverse reactions	Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Glenmark Pharmaceuticals Inc., USA	3c7b3482-e2fd-4857-9394-a47fd7f4c47b	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Proficient Rx LP	96af29b8-16b4-4113-9ec3-338438e11a49	2019-11-01	Adverse reactions	Name fallback brand name: FLUTICASONE PROPIONATE generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUS	FLUTICASONE PROPIONATE	Proficient Rx LP	816e929e-6ba0-437d-80bb-00068419ed53	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Selder, S.A. de C.V.	2da4ba91-c356-473d-b20c-5bb9265767df	2017-11-29	Warnings	Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4e1cd546-4598-115b-0357-5d0c22731faa	2017-11-17	Warnings	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