Application 076793

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	CREAM;TOPICAL	0.05%	No	Yes

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
A076793-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076793-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076793-001	FLUTICASONE PROPIONATE	0.05%	CREAM / TOPICAL	AB	RS	2004-05-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076793-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076793-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076793-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076793-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076793-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076793-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076793-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076793-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076793-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076793-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076793-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076793-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076793-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076793-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076793-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076793-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076793-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076793-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076793-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076793-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076793-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076793-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076793-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076793-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076793-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076793-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076793-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076793-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076793-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076793-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076793-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076793-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076793-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076793-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076793-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076793-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076793-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076793-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076793-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076793-001	AB	1	`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 1 · 6 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	0cd0b88c-1ab3-4699-8eda-554054b8d33c	2025-10-30	Adverse reactions	Exact identifier application applno (ANDA): 076793 application number: ANDA076793
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	36c0e343-5bd4-447e-8651-c5f44d2ffd7c	2025-09-24	Adverse reactions	Exact identifier application applno (ANDA): 076793 application number: ANDA076793 ndc (product): 63629-8659
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	4a4b7242-1083-4912-a318-25c3914aaf22	2024-01-11	Adverse reactions	Exact identifier application applno (ANDA): 076793 application number: ANDA076793 ndc (product): 50090-1187
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	8bd6f3a4-87f7-449e-8fcc-fec1537fcab3	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 076793 application number: ANDA076793 ndc (product): 63629-8660
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	0120296b-bebc-4a2d-8058-6caf41f96e52	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 076793 application number: ANDA076793 ndc (product): 63629-8658
Fluticasone Propionate	FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	78e056e2-d39e-4d20-9ab2-332bd6973619	2022-12-30	Adverse reactions	Exact identifier application applno (ANDA): 076793 application number: ANDA076793 ndc (product): 45802-222

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-222	Fluticasone Propionate	Fluticasone Propionate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-222	Fluticasone Propionate	Fluticasone Propionate	Perrigo New York Inc	ANDA	Current
45802-222	Fluticasone Propionate	Fluticasone Propionate	Perrigo New York Inc	ANDA	Current
50090-1187	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-1187	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
63629-8658	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8658	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8658	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8659	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8659	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8659	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8660	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8660	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
63629-8660	Fluticasone Propionate	Fluticasone Propionate	Bryant Ranch Prepack	ANDA	Current
72835-301	Quinosone	Mometasone Furoate and Ammonium Lactate	V2 Pharma, LLC	ANDA	Current
72835-301	Quinosone	Fluticasone Propionate and Ammonium Lactate	V2 Pharma, LLC	ANDA	Current
76519-1018	Fluticasone Propionate	Fluticasone Propionate	H J Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8963	ORIG	2004-05-26