Application 018849

Type: NDA
Sponsor: CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDEX	FLUOCINONIDE	SOLUTION;TOPICAL	0.05%	Yes	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
N018849-001	LIDEX	FLUOCINONIDE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018849-001	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1984-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL		RLD	1984-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018849-001	LIDEX	0.05%	SOLUTION / TOPICAL	AT	RLD	1984-04-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018849-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018849-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018849-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018849-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018849-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018849-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018849-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018849-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018849-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018849-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018849-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018849-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018849-001	AT	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018849-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018849-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018849-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018849-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018849-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018849-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018849-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018849-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018849-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018849-001	AT	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 2 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Teva Pharmaceuticals USA, Inc.	986c1ba3-2103-4773-a35c-2c0121a01783	2024-09-30	Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Zydus Lifesciences Limited	08d69d3f-c628-4b08-a7ae-0f7ec5599d3a	2024-08-16		Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals, Inc.	51cbe73c-e5d6-1e6a-e054-00144ff88e88	2024-08-14	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals,Inc.	a8eefd01-340e-5eef-e053-2a95a90a802c	2024-07-17	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals,Inc.	8ac0ecd6-38b5-a5f9-e053-2a95a90af412	2024-06-14	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals Inc.	624c81a7-282a-95be-e053-2991aa0a6b44	2024-06-06	Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	3e549888-f5f9-41da-b30d-a499da852282	2024-02-02	Warnings, Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	4fbb3f39-c856-4da6-90b1-a6749de892c5	2024-01-10	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9ee44ed9-e274-4673-8829-0032a36e5b79	2024-01-10	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	0a1dab63-17d0-4ae7-890b-7746be65e29b	2024-01-10	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Asclemed USA, Inc.	cd5d8268-77ff-41c0-8699-b583e52da30c	2023-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Cosette Pharmaceuticals, Inc.	b28c444d-cb70-42c3-a437-c66ae961dbb4	2023-11-22	Adverse reactions	Name fallback 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 generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	50d06efd-9caa-4254-bf1f-eb430c5178b0	2023-03-03	Warnings, Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	34b5a550-4152-4f77-bc07-e4f023fca568	2023-03-03	Warnings, Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Macleods Pharmaceuticals Limited	a439ac59-42f3-412b-b987-14fc152a974f	2023-01-27	Adverse reactions	Name fallback 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 generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Asclemed USA, Inc.	b387f926-1109-41b2-9fe0-f77db6b10280	2022-12-13	Warnings, Adverse reactions	Name fallback 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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43199-031	Fluocinonide	Fluocinonide	County Line Pharmaceuticals, LLC	NDA	Current
47781-602	Fluocinonide	Fluocinonide	Alvogen Inc.	NDA	Current
47781-602	Fluocinonide	Fluocinonide	Alvogen Inc.	NDA	Current
47781-602	Fluocinonide	Fluocinonide	Alvogen Inc.	NDA	Current
47781-602	Fluocinonide	Fluocinonide	Alvogen Inc.	NDA	Current
47781-602	Fluocinonide	Fluocinonide	Alvogen Inc.	NDA	Current
68071-3322	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals,Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16071	SUPPL	2014-03-04
1106	SUPPL	2006-01-19