Application 207680

Type: ANDA
Sponsor: TELIGENT PHARMA INC

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 1.

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
A207680-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL			2018-09-28

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`cb3db0bc1861…`

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	A207680-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207680-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207680-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207680-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207680-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207680-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207680-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207680-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207680-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207680-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207680-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207680-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207680-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207680-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207680-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207680-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207680-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207680-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207680-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207680-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207680-001	AB	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 · 51 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 brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Bryant Ranch Prepack	38a36184-22b4-4e97-83e1-fdd984ef6ccb	2026-05-14	Adverse reactions	Name fallback brand name: Fluocinonide
Fluocinonide	FLUOCINONIDE	Saptalis Pharmaceuticals, LLC.	20f8e9a2-a63d-4bee-bc14-b9f04087d87b	2026-05-11	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Preferred Pharmaceuticals Inc.	80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	2026-04-17	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Preferred Pharmaceuticals Inc.	f5f39a14-005a-4124-9c00-500598e28012	2026-04-17	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Bryant Ranch Prepack	628bda7e-b670-4f71-bcc4-0290d67655a0	2026-04-07	Adverse reactions	Name fallback brand name: Fluocinonide
fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	f20e4aa4-11f3-4f9d-9c29-43f7fb9c549d	2026-03-20	Adverse reactions	Name fallback brand name: fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ab79df76-192b-422e-8d2c-dd5a46ffb216	2026-03-06	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	b1b4a6e9-814e-41e9-9f35-8bed7595265b	2026-02-08	Adverse reactions	Name fallback brand name: Fluocinonide 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 brand name: fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Encube Ethicals, Inc.	4b1f775e-a7ad-4151-975e-6026296b5cea	2026-01-09	Adverse reactions	Name fallback brand name: Fluocinonide
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	b0bc89a9-c9d5-4adb-9785-2d4487c4c656	2025-12-23	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	a2e8aa7a-8996-4dc8-a36b-e8c29fb8540e	2025-12-06	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	NuCare Pharmaceuticals, Inc.	44840256-471b-a719-e063-6394a90a5a14	2025-11-26	Adverse reactions	Name fallback brand name: Fluocinonide
FLUOCINONIDE	FLUOCINONIDE	Encube Ethicals, Inc.	cb869315-8011-485b-8992-1d73fb27e19e	2025-09-09	Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
FLUOCINONIDE	FLUOCINONIDE	QUAGEN PHARMACEUTICALS LLC	272a4467-b5f8-430b-8fab-7fbb07dc8114	2025-08-01	Adverse reactions	Name fallback brand name: FLUOCINONIDE generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	5782d791-48fd-4cee-853d-235eb4d04a40	2025-07-08	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	NorthStar RxLLC	6ae5147c-84c8-4fc8-9bfe-5489e856e890	2025-07-03	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	16c7d142-e695-4e33-986f-78cb37f7b387	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	6fe14034-7703-4aa1-a029-e97c84e02430	2025-07-01	Adverse reactions	Name fallback brand name: Fluocinonide generic name: FLUOCINONIDE

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
52565-040	Fluocinonide	fluocinonide	Teligent Pharma, Inc.	ANDA	Current