Application 209699

Type: ANDA
Sponsor: ENCUBE ETHICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINONIDE	FLUOCINONIDE	SOLUTION;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
A209699-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT		2018-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209699-001	AT

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	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209699-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209699-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209699-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209699-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209699-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209699-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209699-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209699-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209699-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209699-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209699-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209699-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209699-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209699-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209699-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209699-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209699-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209699-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209699-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209699-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209699-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209699-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209699-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209699-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209699-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209699-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209699-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209699-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209699-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209699-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209699-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209699-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209699-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209699-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209699-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209699-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209699-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209699-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209699-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209699-001	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Bryant Ranch Prepack	38a36184-22b4-4e97-83e1-fdd984ef6ccb	2026-05-14	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699 ndc (product): 63629-9583
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Bryant Ranch Prepack	628bda7e-b670-4f71-bcc4-0290d67655a0	2026-04-07	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Encube Ethicals, Inc.	4b1f775e-a7ad-4151-975e-6026296b5cea	2026-01-09	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699 ndc (product): 21922-001
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	NuCare Pharmaceuticals, Inc.	44840256-471b-a719-e063-6394a90a5a14	2025-11-26	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699

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
21922-001	Fluocinonide	fluocinonide topical solution usp, 0.05%	Encube Ethicals Private Limited	ANDA	Current
21922-001	Fluocinonide	fluocinonide topical solution usp, 0.05%	Encube Ethicals Private Limited	ANDA	Current
21922-001	Fluocinonide	fluocinonide topical solution usp, 0.05%	Encube Ethicals Private Limited	ANDA	Current
63629-9583	Fluocinonide	fluocinonide topical solution usp, 0.05%	Bryant Ranch Prepack	ANDA	Current
64980-452	Fluocinonide	Fluocinonide Topical Solution USP, 0.05%	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-452	Fluocinonide	Fluocinonide Topical Solution USP, 0.05%	Rising Pharmaceuticals Inc.	ANDA	Current
64980-452	Fluocinonide	Fluocinonide Topical Solution USP, 0.05%	Rising Pharmaceuticals Inc.	ANDA	Current