Application 209913

Type: ANDA
Sponsor: ENCUBE ETHICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	SOLUTION;TOPICAL	0.01%	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
A209913-001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT		2019-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209913-001	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	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209913-001	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	2019-02-13	`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	A209913-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209913-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209913-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209913-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209913-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209913-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209913-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209913-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209913-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209913-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209913-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209913-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209913-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209913-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209913-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209913-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209913-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209913-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209913-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209913-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209913-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209913-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209913-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209913-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209913-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209913-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209913-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209913-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209913-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209913-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209913-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209913-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209913-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209913-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209913-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209913-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209913-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209913-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209913-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209913-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinolone Acetonide Topical Solution USP, 0.01%	FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%	Encube Ethicals, Inc.	3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36	2026-03-18	Adverse reactions	Exact identifier application applno (ANDA): 209913 application number: ANDA209913 ndc (product): 21922-003
Fluocinolone Acetonide Topical Solution USP, 0.01%	FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%	Bryant Ranch Prepack	3fa4d5db-b17f-44dc-aa6a-50934d42c68d	2026-02-18	Adverse reactions	Exact identifier application applno (ANDA): 209913 application number: ANDA209913
Fluocinolone Acetonide Topical Solution USP, 0.01%	FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%	Bryant Ranch Prepack	ce89966d-d7ea-4986-936e-6d46aee497cd	2024-08-20	Adverse reactions	Exact identifier application applno (ANDA): 209913 application number: ANDA209913 ndc (product): 63629-9584

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-003	Fluocinolone Acetonide Topical Solution USP, 0.01%	Fluocinolone Acetonide Topical Solution USP, 0.01%	Encube Ethicals Private Limited	ANDA	Current
21922-003	Fluocinolone Acetonide Topical Solution USP, 0.01%	Fluocinolone Acetonide Topical Solution USP, 0.01%	Encube Ethicals Private Limited	ANDA	Current
63629-9584	Fluocinolone Acetonide Topical Solution USP, 0.01%	Fluocinolone Acetonide Topical Solution USP, 0.01%	Bryant Ranch Prepack	ANDA	Current