Application 073085

Type: ANDA
Sponsor: ACP NIMBLE

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
A073085-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		1992-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073085-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073085-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1992-02-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A073085-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073085-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073085-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073085-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073085-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073085-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073085-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073085-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073085-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073085-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073085-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073085-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073085-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073085-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073085-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073085-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073085-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073085-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073085-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073085-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073085-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073085-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073085-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073085-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073085-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073085-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073085-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073085-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073085-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073085-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073085-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073085-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073085-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073085-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073085-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073085-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073085-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073085-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073085-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073085-001	AB1	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Preferred Pharmaceuticals Inc.	f5f39a14-005a-4124-9c00-500598e28012	2026-04-17	Adverse reactions	Exact identifier application applno (ANDA): 073085 application number: ANDA073085
Fluocinonide	FLUOCINONIDE	Cosette Pharmaceuticals, Inc.	e3348b90-8c16-4788-ab61-e354aea5d0a8	2022-12-27	Adverse reactions	Exact identifier application applno (ANDA): 073085 application number: ANDA073085 ndc (product): 0713-0663

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0663	Fluocinonide	Fluocinonide	Cosette Pharmaceuticals, Inc.	ANDA	Current
33261-560	Fluocinonide	Fluocinonide	Aidarex Pharmaceuticals LLC	ANDA	Current
51862-494	Fluocinonide	Fluocinonide	Mayne Pharma	ANDA	Current
51862-494	Fluocinonide	Fluocinonide	Mayne Pharma	ANDA	Current
51862-494	Fluocinonide	Fluocinonide	Mayne Pharma	ANDA	Current
53002-9200	Fluocinonide	Fluocinonide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9200	Fluocinonide	Fluocinonide	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-1754	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1754	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1754	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3213	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-7041	Fluocinonide	Fluocinonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7041	Fluocinonide	Fluocinonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7041	Fluocinonide	Fluocinonide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9381	Fluocinonide	Fluocinonide	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-092	Fluocinonide	Fluocinonide	Proficient Rx LP	ANDA	Current
71205-092	Fluocinonide	Fluocinonide	Proficient Rx LP	ANDA	Current