Application 071500

Type: ANDA
Sponsor: TARO

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
A071500-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		1987-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071500-001	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	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`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	A071500-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071500-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071500-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071500-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071500-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071500-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071500-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071500-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071500-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071500-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071500-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071500-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071500-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071500-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071500-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071500-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071500-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071500-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071500-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071500-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071500-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071500-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071500-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071500-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071500-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071500-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071500-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071500-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071500-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071500-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071500-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071500-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071500-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071500-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071500-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071500-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071500-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071500-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071500-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071500-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	a2e8aa7a-8996-4dc8-a36b-e8c29fb8540e	2025-12-06	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500 ndc (product): 50090-3277
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	5782d791-48fd-4cee-853d-235eb4d04a40	2025-07-08	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500 ndc (product): 51672-1386
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals,Inc.	8ac0ecd6-38b5-a5f9-e053-2a95a90af412	2024-06-14	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500 ndc (product): 68071-4921
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals Inc.	624c81a7-282a-95be-e053-2991aa0a6b44	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500 ndc (product): 68071-4219

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2982	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-2982	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-3277	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-3277	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
50090-3277	Fluocinonide	Fluocinonide	A-S Medication Solutions	ANDA	Current
51672-1386	Fluocinonide	Fluocinonide	Taro Pharmaceuticals U.S.A., inc.	ANDA	Current
53002-9202	Fluocinonide	Fluocinonide	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-4219	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals Inc.	ANDA	Current
68071-4219	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals Inc.	ANDA	Current
68071-4219	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals Inc.	ANDA	Current
68071-4921	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4921	Fluocinonide	Fluocinonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
71085-005	Fluocinonide	Fluocinonide	IPG PHARMACEUTICALS, INC.	ANDA	Current