Application 072488

Type: ANDA
Sponsor: TEVA

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
A072488-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		1989-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072488-001	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	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`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	A072488-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072488-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072488-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072488-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072488-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072488-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072488-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072488-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072488-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072488-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072488-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072488-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072488-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072488-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072488-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072488-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072488-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072488-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072488-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072488-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072488-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072488-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072488-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072488-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072488-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072488-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072488-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072488-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072488-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072488-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072488-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072488-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072488-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072488-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072488-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072488-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072488-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072488-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072488-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072488-001	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 · 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	ce75f0e1-c536-40ad-b77f-2e3ec29caeb7	2024-11-06	Adverse reactions	Exact identifier application applno (ANDA): 072488 application number: ANDA072488 ndc (product): 50090-1784
Fluocinonide	FLUOCINONIDE	Teva Pharmaceuticals USA, Inc.	986c1ba3-2103-4773-a35c-2c0121a01783	2024-09-30	Adverse reactions	Exact identifier application applno (ANDA): 072488 application number: ANDA072488 ndc (product): 0093-0262
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals, Inc.	51cbe73c-e5d6-1e6a-e054-00144ff88e88	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 072488 application number: ANDA072488 ndc (product): 66267-973

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
0093-0262	Fluocinonide	Fluocinonide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0262	Fluocinonide	Fluocinonide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0262	Fluocinonide	Fluocinonide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0262	Fluocinonide	Fluocinonide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-1671	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-1784	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-1784	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-2419	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-2419	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-2419	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
53002-9201	Fluocinonide	Fluocinonide	RPK Pharmaceuticals, Inc.	ANDA	Current
66116-512	Fluocinonide	Fluocinonide	MedVantx, Inc.	ANDA	Current
66267-973	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-973	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-973	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6350	Fluocinonide	Fluocinonide	Preferred Pharmaceuticals Inc.	ANDA	Current
76413-107	Fluocinonide	Fluocinonide	Central Texas Community Health Centers	ANDA	Current