Application 021946

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XOLEGEL	KETOCONAZOLE	GEL;TOPICAL	2%	Yes	Yes

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
N021946-001	XOLEGEL	KETOCONAZOLE	2%	GEL / TOPICAL		RLD	2006-07-28

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD	2006-07-28	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021946-001	8232276	2020-11-24	Drug product	2012-08-20	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021946-001	8232276	2020-11-24	Drug product	2012-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021946-001	8232276	2020-11-24	Drug product	2012-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021946-001	8232276	2020-11-24	Drug product	2012-08-20	`ea99ee380514…`

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 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	a878a39d-6d26-4ede-9667-b3e201ffc337	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	2025-10-24	Adverse reactions	Name fallback generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	65dd4435-99f2-4383-b307-ba5bce9f1ca9	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	8ca815a8-bccb-4ee2-a042-922373329cae	2025-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Nizoral	KETOCONAZOLE	Kramer Laboratories	f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88	2025-08-21	Warnings	Name fallback generic name: KETOCONAZOLE
Nizoral	KETOCONAZOLE	Kramer Laboratories	8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6	2025-07-11	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	3e3cde4b-939f-4837-9920-bb6bb8416bd6	2025-07-10	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Amici Pharma Inc.	369f31da-d3c3-49b8-956f-f70598760164	2025-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	39d31bed-9caa-41bb-afdb-25fc18609c14	2025-04-24	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	a884bad7-df8c-45de-8c4f-42034b40e425	2025-04-23	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Tagrit Antifungal Treament Ketoconazole 1%	KETOCONAZOLE	TAGRID LLC	315a8832-c42f-c07a-e063-6394a90a8218	2025-03-27	Warnings	Name fallback generic name: KETOCONAZOLE
1% ketoconazole	KETOCONAZOLE	TAGRID LLC	30b75584-3a1e-c125-e063-6294a90acaa7	2025-03-19	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Zydus Lifesciences Limited	c004ee91-558a-450b-9e4e-d11ab9d28054	2025-03-12		Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Cosette Pharmaceuticals, Inc.	2d7c8dd1-59b5-2645-e063-6394a90a5bda	2025-02-06	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Direct_Rx	f5dc1e67-639f-5476-e053-2995a90a4210	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	Direct Rx	bc189ce2-3f10-260d-e053-2a95a90ae808	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	570acb82-0c6f-0b98-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	ac98307e-315a-4fbd-81cb-cd936f2bfbae	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16110-080	Xolegel	ketoconazole	Almirall, LLC	NDA	Current
16110-080	Xolegel	ketoconazole	Almirall, LLC	NDA	Current
16110-080	Xolegel	ketoconazole	Aqua Pharmaceuticals	NDA	Current
16110-080	Xolegel	ketoconazole	Aqua Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61497	SUPPL	2020-01-02
61460	SUPPL	2019-12-27
37934	SUPPL	2012-05-16
6516	SUPPL	2012-05-14
28903	SUPPL	2010-12-10
16622	SUPPL	2010-12-06
6515	SUPPL	2010-01-05
16621	SUPPL	2010-01-04
16620	SUPPL	2009-01-06
21882	ORIG	2008-09-04
28902	ORIG	2006-08-04
16619	ORIG	2006-08-04