Application 208989

Type: ANDA
Sponsor: CADILA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINONIDE	FLUOCINONIDE	CREAM;TOPICAL	0.1%	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
A208989-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB		2020-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208989-001	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	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`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	A208989-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208989-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208989-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208989-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208989-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208989-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208989-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208989-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208989-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208989-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208989-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208989-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208989-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208989-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208989-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208989-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208989-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208989-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208989-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208989-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208989-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208989-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208989-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208989-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208989-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208989-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208989-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208989-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208989-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208989-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208989-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208989-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208989-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208989-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208989-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208989-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208989-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208989-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOCINONIDE	FLUOCINONIDE	Zydus Lifesciences Limited	08d69d3f-c628-4b08-a7ae-0f7ec5599d3a	2024-08-16		Exact identifier application applno (ANDA): 208989 application number: ANDA208989 ndc (product): 70771-1393
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	3e549888-f5f9-41da-b30d-a499da852282	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	7055d0d3-b148-4ab3-b423-9fc417204b0a	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989 ndc (product): 63629-2508
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	50d06efd-9caa-4254-bf1f-eb430c5178b0	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989 ndc (product): 63629-2510
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	34b5a550-4152-4f77-bc07-e4f023fca568	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989 ndc (product): 63629-2509
FLUOCINONIDE	FLUOCINONIDE	Viona Pharmaceuticals Inc	248675bd-c797-46ab-adf9-f37352c33059	2022-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989 ndc (product): 72578-087

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2508	FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	ANDA	Current
63629-2508	FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	ANDA	Current
63629-2509	FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	ANDA	Current
63629-2509	FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	ANDA	Current
63629-2510	FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	ANDA	Current
63629-2510	FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	ANDA	Current
70771-1393	FLUOCINONIDE	FLUOCINONIDE	Zydus Lifesciences Limited	ANDA	Current
70771-1393	FLUOCINONIDE	FLUOCINONIDE	Cadila Healthcare Limited	ANDA	Current
70771-1393	FLUOCINONIDE	FLUOCINONIDE	Cadila Healthcare Limited	ANDA	Current
72578-087	FLUOCINONIDE	FLUOCINONIDE	Viona Pharmaceuticals Inc	ANDA	Current
72578-087	FLUOCINONIDE	FLUOCINONIDE	Viona Pharmaceuticals Inc	ANDA	Current