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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021946-001	XOLEGEL	2%	GEL / TOPICAL	RLD, RS	2006-07-28	`cb3db0bc1861…`

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 1 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos	KETOCONAZOLE	Guangzhou Xinhongda Trading Service Co., Ltd.	5792eff5-632e-3664-e063-6394a90a8ae3	2026-07-27	Warnings	Name fallback generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	PD-Rx Pharmaceuticals, Inc.	f162e616-21b4-49b1-b437-15e21001a6f0	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Cysndra Ketoconazole 1% Medicated Shampoos	KETOCONAZOLE	Guangzhou Xinhongda Trading Service Co., Ltd.	55ee7358-dfc1-b600-e063-6394a90a49d8	2026-07-06	Warnings	Name fallback generic name: KETOCONAZOLE
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	Warnings	Name fallback generic name: KETOCONAZOLE
Anti-Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	543a431f-21fb-df9e-e063-6394a90a6c36	2026-06-14	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals, Inc.	53492ad1-baca-a7f6-e063-6294a90a2990	2026-06-02	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf8	2026-05-14	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Nizoral	KETOCONAZOLE	Kramer Laboratories	a17b7424-ee7e-4fcc-b6b3-0904932ae319	2026-03-17	Warnings	Name fallback generic name: KETOCONAZOLE
Gembooxt Ketoconazole 1% Medicated Shampoos	KETOCONAZOLE	Guangdong Quadrant Ecological Technology Co., Ltd.	49965e91-43c3-65d7-e063-6294a90abaec	2026-01-30	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	ANI Pharmaceuticals, Inc.	00c1cac8-a865-4583-aaba-3a0f21fb31e6	2026-01-29	Adverse reactions	Name fallback generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	cad7c647-34a9-4e4e-83b3-8d78e58f588f	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NORTHSTAR RX LLC	bf3e48fd-e063-42e6-acd1-580ddc6e93be	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	THIRTY MADISON INC	1f5cd9f4-0db4-4062-b5ec-c33611265e02	2025-12-17	Adverse reactions	Name fallback generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	Strides Pharma Science Limited	6d4be760-c723-4f54-a854-12c61cf91703	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	4578c84a-d438-6740-e063-6294a90a0151	2025-12-08	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Northstar Rx LLC	c4f711dc-d0ea-4beb-9a78-b7e3594ee4be	2025-12-01	Adverse reactions	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	4baebcab-a237-42c0-9183-6f447a44e371	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
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

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