Application 200735

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINONIDE	FLUOCINONIDE	CREAM;TOPICAL	0.1%	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
A200735-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB		2014-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200735-001	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	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200735-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`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	A200735-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200735-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200735-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200735-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200735-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200735-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200735-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200735-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200735-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200735-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200735-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200735-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200735-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200735-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200735-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200735-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200735-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200735-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200735-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200735-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200735-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200735-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200735-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200735-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200735-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200735-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200735-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200735-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200735-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200735-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200735-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200735-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200735-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200735-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200735-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200735-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200735-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200735-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200735-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200735-001	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 2 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	351feec9-2089-e74a-e063-6394a90aa399	2025-05-14	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Padagis Israel Pharmaceuticals Ltd	8e22600e-a1a2-432c-a47c-b7b99a0b1e46	2025-02-27	Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Zydus Lifesciences Limited	72b19e31-49e8-4bd7-8205-997f0c6a43f1	2024-11-30		Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ce75f0e1-c536-40ad-b77f-2e3ec29caeb7	2024-11-06	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Teva Pharmaceuticals USA, Inc.	986c1ba3-2103-4773-a35c-2c0121a01783	2024-09-30	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Zydus Lifesciences Limited	08d69d3f-c628-4b08-a7ae-0f7ec5599d3a	2024-08-16		Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals, Inc.	51cbe73c-e5d6-1e6a-e054-00144ff88e88	2024-08-14	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals,Inc.	a8eefd01-340e-5eef-e053-2a95a90a802c	2024-07-17	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals,Inc.	8ac0ecd6-38b5-a5f9-e053-2a95a90af412	2024-06-14	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals Inc.	624c81a7-282a-95be-e053-2991aa0a6b44	2024-06-06	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	3e549888-f5f9-41da-b30d-a499da852282	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	4fbb3f39-c856-4da6-90b1-a6749de892c5	2024-01-10	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9ee44ed9-e274-4673-8829-0032a36e5b79	2024-01-10	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	0a1dab63-17d0-4ae7-890b-7746be65e29b	2024-01-10	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Asclemed USA, Inc.	cd5d8268-77ff-41c0-8699-b583e52da30c	2023-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Cosette Pharmaceuticals, Inc.	b28c444d-cb70-42c3-a437-c66ae961dbb4	2023-11-22	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide Cream	FLUOCINONIDE	Amneal Pharmaceuticals NY LLC	817cac6b-fec5-406d-aa0c-8852d08a3c65	2023-06-06	Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	7055d0d3-b148-4ab3-b423-9fc417204b0a	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	50d06efd-9caa-4254-bf1f-eb430c5178b0	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	34b5a550-4152-4f77-bc07-e4f023fca568	2023-03-03	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0457	fluocinonide	fluocinonide	Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0457	fluocinonide	fluocinonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32054	ORIG	2014-07-15