Application 212976

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINONIDE	FLUOCINONIDE	OINTMENT;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
A212976-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB		2019-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212976-001	AB

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.

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	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212976-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2019-11-26	`a50c72e98297…`

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	A212976-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212976-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212976-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212976-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212976-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212976-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212976-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212976-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212976-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212976-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212976-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212976-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212976-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212976-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212976-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212976-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212976-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212976-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212976-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212976-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212976-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212976-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212976-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212976-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212976-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212976-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212976-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212976-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212976-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212976-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212976-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212976-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212976-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212976-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212976-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212976-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212976-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212976-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212976-001	AB	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9bad56f2-6070-44fc-a39d-bb00280057f0	2026-06-01	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	4fbb3f39-c856-4da6-90b1-a6749de892c5	2024-01-10	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976 ndc (product): 63629-2339
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	9ee44ed9-e274-4673-8829-0032a36e5b79	2024-01-10	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976 ndc (product): 63629-2337
Fluocinonide	FLUOCINONIDE	Bryant Ranch Prepack	0a1dab63-17d0-4ae7-890b-7746be65e29b	2024-01-10	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976 ndc (product): 63629-2338
Fluocinonide	FLUOCINONIDE	Xiromed LLC	d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc	2020-01-13	Adverse reactions	Exact identifier application applno (ANDA): 212976 application number: ANDA212976 ndc (product): 70700-146

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2337	Fluocinonide	Fluocinonide	Bryant Ranch Prepack	ANDA	Current
63629-2337	Fluocinonide	Fluocinonide	Bryant Ranch Prepack	ANDA	Current
63629-2338	Fluocinonide	Fluocinonide	Bryant Ranch Prepack	ANDA	Current
63629-2338	Fluocinonide	Fluocinonide	Bryant Ranch Prepack	ANDA	Current
63629-2339	Fluocinonide	Fluocinonide	Bryant Ranch Prepack	ANDA	Current
63629-2339	Fluocinonide	Fluocinonide	Bryant Ranch Prepack	ANDA	Current
70700-146	Fluocinonide	Fluocinonide	Xiromed LLC	ANDA	Current
70700-146	Fluocinonide	Fluocinonide	Xiromed LLC	ANDA	Current
70700-146	Fluocinonide	Fluocinonide	Xiromed LLC	ANDA	Current
70700-146	Fluocinonide	Fluocinonide	Xiromed LLC	ANDA	Current