Application 016908

Type: NDA
Sponsor: CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	LIDEX	FLUOCINONIDE	CREAM;TOPICAL	0.05%	Yes	No
003	LIDEX-E	FLUOCINONIDE	CREAM;TOPICAL	0.05%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016908-002	LIDEX	FLUOCINONIDE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982
N016908-003	LIDEX-E	FLUOCINONIDE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	AB2	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016908-002	LIDEX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016908-002	LIDEX	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016908-003	LIDEX-E	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`3a93d1ddd44b…`

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	N016908-003	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016908-003	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016908-003	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016908-003	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016908-003	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016908-003	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016908-003	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016908-003	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016908-003	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016908-003	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016908-003	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016908-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016908-003	AB2	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016908-003	AB2	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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9bad56f2-6070-44fc-a39d-bb00280057f0	2026-06-01	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Saptalis Pharmaceuticals, LLC.	20f8e9a2-a63d-4bee-bc14-b9f04087d87b	2026-05-11	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Preferred Pharmaceuticals Inc.	80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	2026-04-17	Adverse reactions	Name fallback generic name: FLUOCINONIDE
fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	f20e4aa4-11f3-4f9d-9c29-43f7fb9c549d	2026-03-20	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ab79df76-192b-422e-8d2c-dd5a46ffb216	2026-03-06	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	b1b4a6e9-814e-41e9-9f35-8bed7595265b	2026-02-08	Adverse reactions	Name fallback generic name: FLUOCINONIDE
fluocinonide	FLUOCINONIDE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	ebca0c66-06f6-438a-a01a-634c53debc06	2026-01-28	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	b0bc89a9-c9d5-4adb-9785-2d4487c4c656	2025-12-23	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	a2e8aa7a-8996-4dc8-a36b-e8c29fb8540e	2025-12-06	Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Encube Ethicals, Inc.	cb869315-8011-485b-8992-1d73fb27e19e	2025-09-09	Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	QUAGEN PHARMACEUTICALS LLC	272a4467-b5f8-430b-8fab-7fbb07dc8114	2025-08-01	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	5782d791-48fd-4cee-853d-235eb4d04a40	2025-07-08	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NorthStar RxLLC	6ae5147c-84c8-4fc8-9bfe-5489e856e890	2025-07-03	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	16c7d142-e695-4e33-986f-78cb37f7b387	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	6fe14034-7703-4aa1-a029-e97c84e02430	2025-07-01	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	351feec9-2089-e74a-e063-6394a90aa399	2025-05-14	Adverse reactions	Name fallback generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	Padagis Israel Pharmaceuticals Ltd	8e22600e-a1a2-432c-a47c-b7b99a0b1e46	2025-02-27	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Zydus Lifesciences Limited	72b19e31-49e8-4bd7-8205-997f0c6a43f1	2024-11-30		Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ce75f0e1-c536-40ad-b77f-2e3ec29caeb7	2024-11-06	Adverse reactions	Name fallback generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Teva Pharmaceuticals USA, Inc.	986c1ba3-2103-4773-a35c-2c0121a01783	2024-09-30	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-532	Fluocinonide Cream (Emulsified Base)	Fluocinonide Cream (Emulsified Base)	Alvogen Inc.	NDA	Current
47781-532	Fluocinonide Cream (Emulsified Base)	Fluocinonide Cream (Emulsified Base)	Alvogen Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
515	SUPPL	2006-01-19