Application 210554

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINONIDE	FLUOCINONIDE	CREAM;TOPICAL	0.05%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210554-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210554-001	AB1

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 · 42 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
2026-08-18 06:07:40	2026-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210554-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210554-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210554-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210554-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210554-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210554-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210554-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210554-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210554-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210554-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210554-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210554-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210554-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210554-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210554-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210554-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210554-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210554-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210554-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210554-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210554-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210554-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210554-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210554-001	AB1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210554-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210554-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210554-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210554-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210554-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210554-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210554-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210554-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210554-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210554-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210554-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210554-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210554-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210554-001	AB1	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ab79df76-192b-422e-8d2c-dd5a46ffb216	2026-03-06	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	b1b4a6e9-814e-41e9-9f35-8bed7595265b	2026-02-08	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554 ndc (product): 50090-6309
Fluocinonide Cream	FLUOCINONIDE	Amneal Pharmaceuticals NY LLC	817cac6b-fec5-406d-aa0c-8852d08a3c65	2023-06-06	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554 ndc (product): 69238-1534

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6309	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
68071-2667	Fluocinonide Cream	Fluocinonide	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-2808	Fluocinonide Cream	Fluocinonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8105	Fluocinonide Cream	Fluocinonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8105	Fluocinonide Cream	Fluocinonide	Preferred Pharmaceuticals Inc.	ANDA	Current
69238-1534	Fluocinonide Cream	Fluocinonide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1534	Fluocinonide Cream	Fluocinonide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1534	Fluocinonide Cream	Fluocinonide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1534	Fluocinonide Cream	Fluocinonide	Amneal Pharmaceuticals LLC	ANDA	Current