Application 207957

Type: ANDA
Sponsor: HIKMA

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
A207957-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		RS	2016-05-26

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Welby Fluticasone	FLUTICASONE PROPIONATE	Aldi Inc	446bfcd9-8f28-4a96-840f-c72ac5970408	2022-11-03	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
topcare fluticasone propionate nasal	FLUTICASONE PROPIONATE	Topco Associates LLC	f7c425d2-4afb-478f-83bc-eb336910233b	2022-11-01	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957 ndc (product): 36800-222
equate allergy relief	FLUTICASONE PROPIONATE	Wal-Mart Stores Inc	959167e8-f4a1-49b9-b3a6-f0d0b3d7d477	2022-10-14	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957

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 3 · 166 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0028	Good Sense 24 hour allergy nasal	Fluticasone propionate	L. Perrigo Company	ANDA	Current
0113-0028	Good Sense 24 hour allergy nasal	Fluticasone propionate	L. Perrigo Company	ANDA	Current
0113-0028	Good Sense 24 hour allergy nasal	Fluticasone propionate	L. Perrigo Company	ANDA	Current
0113-0285	Good Sense 24 hour allergy nasal	Fluticasone Propionate	L. Perrigo Company	ANDA	Current
0113-0285	Good Sense 24 hour allergy nasal	Fluticasone Propionate	L. Perrigo Company	ANDA	Current
0113-0285	Good Sense 24 hour allergy nasal	Fluticasone Propionate	L. Perrigo Company	ANDA	Current
0113-7117	basic care allergy relief nasal	Fluticasone propionate	L. Perrigo Company	ANDA	Current
0363-0024	24 Hour Allergy Nasal	Fluticasone propionate	Walgreen Company	ANDA	Current
0363-0024	24 Hour Allergy Nasal	Fluticasone propionate	Walgreen Company	ANDA	Current
0363-0024	24 Hour Allergy Nasal	Fluticasone propionate	Walgreen Company	ANDA	Current
0363-0024	24 Hour Allergy Nasal	Fluticasone propionate	Walgreen Company	ANDA	Current
0363-0024	24 Hour Allergy Nasal	Fluticasone propionate	Walgreen Company	ANDA	Current
0363-0881	Allergy Nasal	Fluticasone Propionate	Walgreen Company	ANDA	Current
0363-0881	Allergy Nasal	Fluticasone Propionate	Walgreen Company	ANDA	Current
0363-0881	Allergy Nasal	Fluticasone Propionate	Walgreen Company	ANDA	Current
0363-1205	childrens nasal	Fluticasone Propionate	Walgreen Company	ANDA	Current
0536-1183	RUGBY FLUTICASONE PROPIONATE NASAL	Fluticasone propionate	Rugby Laboratories	ANDA	Current
0536-1183	RUGBY FLUTICASONE PROPIONATE NASAL	Fluticasone propionate	Rugby Laboratories	ANDA	Current
0536-1183	RUGBY FLUTICASONE PROPIONATE NASAL	Fluticasone propionate	Rugby Laboratories	ANDA	Current
0536-1183	RUGBY FLUTICASONE PROPIONATE NASAL	Fluticasone propionate	Rugby Laboratories	ANDA	Current
11673-103	Up and Up Allergy Relief Nasal	Fluticasone propionate	Target Corporation	ANDA	Current
11673-103	Up and Up Allergy Relief Nasal	Fluticasone propionate	Target Corporation	ANDA	Current
11673-103	Up and Up Allergy Relief Nasal	Fluticasone propionate	Target Corporation	ANDA	Current
11673-103	Up and Up Allergy Relief Nasal	Fluticasone propionate	Target Corporation	ANDA	Current
11673-103	Up and Up Allergy Relief Nasal	Fluticasone propionate	Target Corporation	ANDA	Current
11673-103	Up and Up Allergy Relief Nasal	Fluticasone propionate	Target Corporation	ANDA	Current
11673-388	Up and Up allergy relief nasal	Fluticasone Propionate	Target Corporation	ANDA	Current
11822-0901	allergy nasal	Fluticasone propionate	Rite Aid Corporation	ANDA	Current
11822-0901	allergy nasal	Fluticasone propionate	Rite Aid Corporation	ANDA	Current
11822-0901	allergy nasal	Fluticasone propionate	Rite Aid Corporation	ANDA	Current
11822-1177	childrens allergy nasal	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
11822-1177	childrens allergy nasal	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
21130-089	Signature Care Allergy Relief	Fluticasone propionate	Safeway	ANDA	Current
21130-089	Signature Care Allergy Relief	Fluticasone propionate	Safeway	ANDA	Current
21130-089	Signature Care Allergy Relief	Fluticasone propionate	Safeway	ANDA	Current
21130-089	Signature Care Allergy Relief	Fluticasone propionate	Safeway	ANDA	Current
21130-089	Signature Care Allergy Relief	Fluticasone propionate	Safeway	ANDA	Current
21130-122	signature care childrens allergy relief	Fluticasone Propionate	Safeway	ANDA	Current
21130-122	signature care childrens allergy relief	Fluticasone Propionate	Safeway	ANDA	Current
21130-122	signature care childrens allergy relief	Fluticasone Propionate	Safeway	ANDA	Current
30142-301	24 Hour Allergy Relief nasal	Fluticasone propionate	Kroger Company	ANDA	Current
30142-301	24 Hour Allergy Relief nasal	Fluticasone propionate	Kroger Company	ANDA	Current
30142-387	Childrens 24 Hour Allergy Relief Nasal	Fluticasone Propionate	Kroger Company	ANDA	Current
30142-767	allergy relief nasal	Fluticasone propionate	Kroger Company	ANDA	Current
30142-767	allergy relief nasal	Fluticasone propionate	Kroger Company	ANDA	Current
36800-128	TopCare Childrens Allergy Relief Nasal 24 Hour	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-128	TopCare Childrens Allergy Relief Nasal 24 Hour	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-128	TopCare Childrens Allergy Relief Nasal 24 Hour	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-128	TopCare Childrens Allergy Relief Nasal 24 Hour	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-222	topcare fluticasone propionate nasal	Fluticasone propionate	Topco Associates LLC	ANDA	Current
36800-222	topcare fluticasone propionate nasal	Fluticasone propionate	Topco Associates LLC	ANDA	Current
36800-222	topcare fluticasone propionate nasal	Fluticasone propionate	Topco Associates LLC	ANDA	Current
36800-315	TopCare Nasoflow Allergy Relief	Fluticasone propionate	Topco Associates LLC	ANDA	Current
37012-007	Nasoflow	Fluticasone propionate	Shopko Stores Operating Co., LLC	ANDA	Current
37012-307	24 hour allergy nasal	Fluticasone propionate	Shopko Stores Operating Co., LLC	ANDA	Current
37808-075	Nasoflow	Fluticasone propionate	H E B	ANDA	Current
37808-205	Nasopro 24	Fluticasone propionate	H E B	ANDA	Current
37808-205	Nasopro 24	Fluticasone propionate	H E B	ANDA	Current
37808-205	Nasopro 24	Fluticasone propionate	H E B	ANDA	Current
37808-340	Childrens Nasopro	fluticasone propionate	H E B	ANDA	Current
37808-340	Childrens Nasopro	fluticasone propionate	H E B	ANDA	Current
37808-340	Childrens Nasopro	fluticasone propionate	H E B	ANDA	Current
41163-023	Equaline Fluticasone Propionate	Fluticasone propionate	Supervalu Inc	ANDA	Current
41163-023	Equaline Fluticasone Propionate	Fluticasone propionate	Supervalu Inc	ANDA	Current
41163-023	Equaline Fluticasone Propionate	Fluticasone propionate	Supervalu Inc	ANDA	Current
41163-100	Equaline fluticasone propionate	Fluticasone Propionate	Supervalu Inc	ANDA	Current
41190-004	ShopRite Allergy Relief Nasal	Fluticasone propionate	Wakefern Food Corporation	ANDA	Current
41250-634	Allergy Relief	Fluticasone propionate	Meijer Distribution Inc	ANDA	Current
41250-634	Allergy Relief	Fluticasone propionate	Meijer Distribution Inc	ANDA	Current
41250-634	Allergy Relief	Fluticasone propionate	Meijer Distribution Inc	ANDA	Current
41250-933	24 hour allergy relief nasal	Fluticasone propionate	Meijer Distribution Inc	ANDA	Current
41250-933	24 hour allergy relief nasal	Fluticasone propionate	Meijer Distribution Inc	ANDA	Current
41250-933	24 hour allergy relief nasal	Fluticasone propionate	Meijer Distribution Inc	ANDA	Current
41520-007	careone fluticasone propionate	Fluticasone propionate	American Sales Company	ANDA	Current
41520-553	careone childrens allergy relief	Fluticasone Propionate	American Sales Company	ANDA	Current
41520-703	CareOne Allergy Relief	Fluticasone propionate	American Sales Company	ANDA	Current
41520-703	CareOne Allergy Relief	Fluticasone propionate	American Sales Company	ANDA	Current
42507-818	24 Hour Allergy Nasal	Fluticasone propionate	HyVee Inc	ANDA	Current
46122-338	Good Neighbor Pharmacy Fluticasone Propionate	Fluticasone propionate	Amerisource Bergen	ANDA	Current
46122-338	Good Neighbor Pharmacy Fluticasone Propionate	Fluticasone propionate	Amerisource Bergen	ANDA	Current