Application 076504

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076504-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076504-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076504-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2006-02-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076504-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076504-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076504-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076504-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076504-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076504-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076504-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076504-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076504-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076504-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076504-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076504-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076504-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076504-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076504-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076504-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076504-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076504-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076504-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076504-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076504-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076504-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076504-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076504-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076504-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076504-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076504-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076504-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076504-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076504-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076504-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076504-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076504-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076504-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076504-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076504-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076504-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076504-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076504-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076504-001	AB	1	`cb3db0bc1861…`

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Golden State Medical Supply, Inc.	534d78c5-4ba0-4ab1-e063-6294a90a8ff7	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	0a3447a1-407c-40a8-99bb-7e9a86eb37df	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	REMEDYREPACK INC.	3c7e3ae6-a78f-4023-a2d4-543615ae25b0	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504 ndc (product): 70518-0880
Fluticasone Propionate	FLUTICASONE PROPIONATE	Hikma Pharmaceuticals USA Inc.	0d9a521b-8314-437c-8c9f-f6188f1134fe	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504 ndc (product): 0054-3270
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	6e2d11f9-94d8-4434-b46b-8e2fcc9276fb	2025-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	3b1849e1-bd0b-42e4-a4ac-f156dc18604a	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504 ndc (product): 50090-2880
Fluticasone Propionate	FLUTICASONE PROPIONATE	Proficient Rx LP	ab8c172b-c369-4372-95f9-dd1a28b3982b	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504 ndc (product): 63187-806
Fluticasone Propionate	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals,Inc.	8761a5e1-a9cb-0622-e053-2a95a90a3504	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076504 application number: ANDA076504 ndc (product): 68071-4868

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3270	Fluticasone Propionate	Fluticasone Propionate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3270	Fluticasone Propionate	Fluticasone Propionate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3270	Fluticasone Propionate	Fluticasone Propionate	West-Ward Pharmaceuticals Corp.	ANDA	Current
50090-2879	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-2880	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-2880	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-2880	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
55700-460	Fluticasone Propionate	Fluticasone Propionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-611	FLUTICASONE	FLUTICASONE	Direct RX	ANDA	Current
63187-806	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
63187-806	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
63187-806	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
63187-806	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
68071-4868	Fluticasone Propionate	Fluticasone Propionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4868	Fluticasone Propionate	Fluticasone Propionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7658	Fluticasone Propionate	Fluticasone Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7658	Fluticasone Propionate	Fluticasone Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0880	Fluticasone Propionate	Fluticasone Propionate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22566	ORIG	2011-01-04
8919	ORIG	2006-03-01