Application 207347

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	OIL;TOPICAL	0.01%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207347-001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT		2023-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207347-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207347-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2023-08-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207347-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207347-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207347-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207347-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207347-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207347-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207347-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207347-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207347-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207347-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207347-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207347-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207347-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207347-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207347-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207347-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207347-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207347-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207347-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207347-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207347-001	AT	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207347-001	AT	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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	ba20d901-f800-4edd-aac6-6c77cbfe1064	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	e6af2549-50b5-4b7f-a0c0-de0f7626b6f3	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	7f8512d9-b4a4-43c6-bac6-3e75dc451db2	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide Oil	FLUOCINOLONE ACETONIDE	A-S Medication Solutions	0ff97af2-04d6-478e-8abe-ca5a0c675708	2025-07-10	Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	02352ed1-3568-441f-add8-45201351a11c	2025-07-03	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	22e9909a-47d2-4331-9b92-e7c4c2acf739	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
DERMOTIC	FLUOCINOLONE ACETONIDE	Royal Pharmaceuticals	eb00f222-8105-4e05-90e8-bbd129784364	2025-05-09	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Flac Otic Oil	FLUOCINOLONE ACETONIDE	Patrin Pharma, Inc.	4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb	2024-11-19	Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	7954bdec-1b75-41d1-8c19-500eceaf6655	2024-11-08	Adverse reactions	Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	8ca4528d-7afa-451e-97ae-9c1c21c07a6e	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Synalar	FLUOCINOLONE ACETONIDE	Medimetriks Pharmaceuticals, Inc.	5af2e4c1-082b-48a0-aae7-72d4a68cbb2d	2024-07-18	Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	c9e2b99e-1f64-4c21-99a7-a18963be2237	2024-05-24	Adverse reactions	Name fallback brand name: Fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	71541422-f12c-4e92-8012-dba59112070c	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Synalar	FLUOCINOLONE ACETONIDE	Medimetriks Pharmaceuticals, Inc.	d2d155cf-a635-4ab7-87de-34e90b9a74cd	2023-11-29	Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd	2023-11-22	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Quagen Pharmaceuticals LLC	a625fe98-8630-4b27-b2fc-4b045847d8f1	2023-02-26	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Quagen Pharmaceuticals LLC	fa5eba5b-57bf-4d46-b0e1-c7104542cb46	2023-02-26	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	Quagen Pharmaceuticals LLC	2bcea813-d629-42c5-8953-fa231b4cbf58	2023-02-26	Adverse reactions	Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	a6e77bc5-ddb3-491a-bf16-d6d253886bb0	2022-11-16	Adverse reactions	Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Lupin Pharmaceuticals,Inc.	460f5a55-6437-4651-bc08-8063ca579c8d	2019-02-21	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.