Application 074905

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINONIDE	FLUOCINONIDE	OINTMENT;TOPICAL	0.05%	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
A074905-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB		1997-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074905-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074905-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	1997-08-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074905-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074905-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074905-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074905-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074905-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074905-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074905-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074905-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074905-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074905-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074905-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074905-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074905-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074905-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074905-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074905-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074905-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074905-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074905-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074905-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074905-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074905-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074905-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074905-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074905-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074905-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074905-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074905-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074905-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074905-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074905-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074905-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074905-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074905-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074905-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074905-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074905-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074905-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074905-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074905-001	AB	1	`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 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Macleods Pharmaceuticals Limited	a439ac59-42f3-412b-b987-14fc152a974f	2023-01-27	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinol Pak	FLUOCINONIDE	PureTek Corporation	a9c88a41-3ff8-78f7-e053-2995a90adb8f	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Cosette Pharmaceuticals, Inc.	e3348b90-8c16-4788-ab61-e354aea5d0a8	2022-12-27	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Asclemed USA, Inc.	b387f926-1109-41b2-9fe0-f77db6b10280	2022-12-13	Warnings, Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Viona Pharmaceuticals Inc	248675bd-c797-46ab-adf9-f37352c33059	2022-10-04	Warnings, Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Zydus Pharmaceuticals USA Inc.	73315c87-4e55-41ea-883b-23d504c1b10d	2022-10-04	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Xiromed LLC	d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc	2020-01-13	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Lupin Pharmaceuticals,Inc.	43b7621c-6628-4b54-af32-32efd0f722da	2018-12-20	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
fluocinonide	FLUOCINONIDE	Novel Laboratories, Inc.	f820f497-9ad9-482d-ac92-46a7afa58968	2016-09-21	Adverse reactions	Name fallback brand name: fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Glenmark Pharmaceuticals Inc., USA	50f1c216-78c6-4b93-b732-b3beeb78bd62	2014-09-30	Warnings, Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0140	Fluocinonide	fluocinonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22380	ORIG	1997-08-26