Application 208150

Type: ANDA
Sponsor: APOTEX

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 42.

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
A208150-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL			2016-02-29

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`e64feba35796…`

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 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Walgreens	16756136-e813-8a91-3351-7e759d1b4b94	2026-08-17	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 0363-0652
Fluticasone Propionate	FLUTICASONE PROPIONATE	The Kroger Co.	f05689fa-7ff3-0846-c647-bdbe79cb2ff8	2026-07-29	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 30142-258
Fluticasone Propionate	FLUTICASONE PROPIONATE	P & L Development, LLC	e3347976-facd-49b6-9ae1-7ed3cd02ba96	2026-07-02	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Chain Drug Marketing Association, Inc.	0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc7	2026-07-02	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Allergy Relief	FLUTICASONE PROPIONATE	P & L Development, LLC	f83fabaa-1c6c-4a19-9f30-2f06df6d48f4	2026-05-26	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	f4b9fcfc-f3f7-4ce0-8f97-3d475081aa67	2026-04-29	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Grocery Outlet	838bbb29-0aa3-4c88-a10d-81be71c20211	2026-03-16	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	e3c861e3-2507-9758-fcd0-8e82d721b5b4	2026-03-06	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 60505-0955
Fluticasone Propionate	FLUTICASONE PROPIONATE	Sam's West, Inc	d2a6e22c-1159-c86a-b927-e7ace1d7023f	2025-10-24	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Allergy Relief	FLUTICASONE PROPIONATE	Discount Drug Mart	9b6791d9-f8e8-5ae6-fbdd-c96561c0976a	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 53943-006
Fluticasone Propionate	FLUTICASONE PROPIONATE	Sam's West Inc.	0370ef12-9199-e2ef-ef85-7d2c7d413bc9	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Allergy Relief	FLUTICASONE PROPIONATE	Quality Home Products	7c81d4d6-d688-72ab-9e43-9b2278d1e057	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	1252da79-70c1-c46e-e92b-a4edba76b178	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 60505-6205
Allergy Relief Nasal	ALLERGY RELIEF NASAL	Marc Glassman, Inc.	bf100c3f-b1f4-4efa-af88-b51ed2a21771	2025-08-08	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Walmart	8616944c-a684-085a-7106-cf034e3f6f4d	2025-07-01	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 49035-362
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bi-Mart	3e4ff2eb-0d99-4ce7-910e-81f878b2231e	2025-05-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 37835-997
Fluticasone Propionate	FLUTICASONE PROPIONATE	TWIN MED LLC	9337aa4b-382d-4ab9-b312-60417cdd40cf	2025-05-01	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Target Corporation	cee73f84-40fb-7143-0f11-4d119de6a905	2025-02-13	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150 ndc (product): 11673-262
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4250d331-17b0-46be-a779-fb4f09bade16	2024-04-11	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	a4e1c265-5205-4089-8190-0755ede83896	2023-11-28	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 130 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0280-0072	ClariSpray	Fluticasone propionate (glucocorticoid)	Bayer HealthCare LLC.	ANDA	Current
0363-0652	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-0652	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-0652	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-0652	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-5010	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-5010	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-5012	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0363-5012	Fluticasone Propionate	Fluticasone Propionate	Walgreens	ANDA	Current
0536-1091	Fluticasone Propionate	Fluticasone Propionate	Rugby Laboratories	ANDA	Current
0536-1091	Fluticasone Propionate	Fluticasone Propionate	Rugby Laboratories	ANDA	Current
11673-220	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-220	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-220	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-220	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-221	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-221	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-262	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-262	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11673-262	Fluticasone Propionate	Fluticasone Propionate	Target Corporation	ANDA	Current
11822-5000	Fluticasone Propionate	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
11822-5000	Fluticasone Propionate	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
11822-5001	Fluticasone Propionate	Fluticasone Propionate	Rite Aid	ANDA	Current
11822-5001	Fluticasone Propionate	Fluticasone Propionate	Rite Aid	ANDA	Current
11822-7003	Fluticasone Propionate	Fluticasone Propionate	Rite Aid	ANDA	Current
11822-7003	Fluticasone Propionate	Fluticasone Propionate	Rite Aid	ANDA	Current
11822-7003	Fluticasone Propionate	Fluticasone Propionate	Rite Aid	ANDA	Current
11822-7003	Fluticasone Propionate	Fluticasone Propionate	Rite Aid	ANDA	Current
11822-7005	Fluticasone Propionate	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
11822-7005	Fluticasone Propionate	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
11822-7005	Fluticasone Propionate	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
11822-7005	Fluticasone Propionate	Fluticasone Propionate	Rite Aid Corporation	ANDA	Current
21130-680	Fluticasone Propionate	Fluticasone Propionate	Safeway	ANDA	Current
21130-680	Fluticasone Propionate	Fluticasone Propionate	Safeway	ANDA	Current
30142-258	Fluticasone Propionate	Fluticasone Propionate	Kroger Company	ANDA	Current
30142-258	Fluticasone Propionate	Fluticasone Propionate	Kroger Company	ANDA	Current
30142-258	Fluticasone Propionate	Fluticasone Propionate	Kroger Company	ANDA	Current
36800-028	Fluticasone Propionate	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-028	Fluticasone Propionate	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-572	Allergy Relief	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-572	Allergy Relief	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
36800-572	Allergy Relief	Fluticasone Propionate	Topco Associates LLC	ANDA	Current
37835-997	Fluticasone Propionate	Fluticasone Propionate	Bi-Mart	ANDA	Current
37835-997	Fluticasone Propionate	Fluticasone Propionate	Bi-Mart	ANDA	Current
37835-997	Fluticasone Propionate	Fluticasone Propionate	Bi-Mart	ANDA	Current
49035-060	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-060	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-063	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-063	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-063	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-063	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-362	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-362	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-362	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-362	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-362	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-362	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
49035-501	Fluticasone Propionate	Fluticasone Propionate	Walmart	ANDA	Current
53943-006	Allergy Relief	Fluticasone Propionate	Discount Drug Mart	ANDA	Current
53943-006	Allergy Relief	Fluticasone Propionate	Discount Drug Mart	ANDA	Current
53943-006	Allergy Relief	Fluticasone Propionate	Discount Drug Mart	ANDA	Current
53943-500	Fluticasone Propionate	Fluticasone Propionate	Discount Drug Mart	ANDA	Current
55315-800	Fluticasone Propionate	Fluticasone Propionate	Freds Inc	ANDA	Current
55315-800	Fluticasone Propionate	Fluticasone Propionate	Freds Inc	ANDA	Current
55315-825	Fluticasone Propionate	Fluticasone Propionate	Freds Inc	ANDA	Current
55315-825	Fluticasone Propionate	Fluticasone Propionate	Freds Inc	ANDA	Current
59779-418	Fluticasone Propionate	Fluticasone Propionate	CVS Pharmacy	ANDA	Current
60505-0955	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0955	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0955	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6134	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6134	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6134	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6134	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6167	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6167	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6201	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6201	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6205	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-6205	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current