Application 088169

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	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
A088169-001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT		1982-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088169-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A088169-001	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT		1982-12-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A088169-001	AT	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 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	Bryant Ranch Prepack	30b0013a-d289-4230-8f50-0a0ff05f4b5e	2026-06-18	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Derma-Smoothe/FS	FLUOCINOLONE ACETONIDE	Royal Pharmaceuticals, LLC	bc61c619-a71c-46f5-80f1-9e9ee71134aa	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	Royal Pharmaceuticals	113e167a-a9fe-440e-9446-d6d87963ef46	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	4790bdfa-c964-4c3e-9d01-c2fb23a0172e	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	A-S Medication Solutions	09284ede-6be9-4192-b178-567b3c6265bb	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Retisert	FLUOCINOLONE ACETONIDE	Bausch & Lomb Incorporated	1ab0f849-2a0d-47ce-ad05-768094da8cc9	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide Oil	FLUOCINOLONE ACETONIDE	Rising Pharma Holdings, Inc.	79591576-1eab-48c5-b0a6-e205b3cc097e	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide Oil	FLUOCINOLONE ACETONIDE	Rising Pharma Holdings, Inc.	f45b0ef2-1702-4d21-8ac8-774769304595	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	50e7006d-a51b-49aa-8e1c-330340e7bf82	2026-02-23	Adverse reactions	Name fallback brand name: fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	622c9804-0be0-4dec-a6ba-5cf4b5578a84	2026-02-23	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
YUTIQ	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	f270cad8-ed82-4969-b785-831a1910bfa6	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	49552e29-7813-4726-b15d-63bd975b6588	2026-01-28	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Iluvien	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	4400e471-7402-11df-93f2-0800200c9a66	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Fougera Pharmaceuticals, LLC	5649e15a-6a7c-4752-ac28-01e453afb37e	2026-01-28	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE Oil	FLUOCINOLONE ACETONIDE	RISING PHARMA HOLDINGS, INC.	f4a58ecc-cd50-4414-add1-a82b09da2058	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	f7861aba-f199-4fe4-90cc-bebea55b3b5f	2025-11-11	Adverse reactions	Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	1539d6ac-b527-4ff0-afe4-083ceac655f3	2025-11-11	Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	f674a0c0-df04-47e8-8d3f-a370182a596a	2025-10-29	Adverse reactions	Name fallback brand name: Fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	b6796a10-9c90-429d-bfd6-33b557dc952c	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0060	Fluocinolone Acetonide	fluocinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current