Application 020001

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPEX	FLUOCINOLONE ACETONIDE	SHAMPOO;TOPICAL	0.01%	Yes	Yes

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
N020001-001	CAPEX	FLUOCINOLONE ACETONIDE	0.01%	SHAMPOO / TOPICAL		RLD	1990-08-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD	1990-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020001-001	CAPEX	0.01%	SHAMPOO / TOPICAL	RLD, RS	1990-08-27	`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 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 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 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 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 generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	622c9804-0be0-4dec-a6ba-5cf4b5578a84	2026-02-23	Adverse reactions	Name fallback 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 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 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 generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	1539d6ac-b527-4ff0-afe4-083ceac655f3	2025-11-11	Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b	2025-11-10	Warnings, Adverse reactions	Name fallback generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	f674a0c0-df04-47e8-8d3f-a370182a596a	2025-10-29	Adverse reactions	Name fallback 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 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
0299-5500	Capex	fluocinolone acetonide	Galderma Laboratories, L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19925	SUPPL	2015-12-18