Application 018738

Type: NDA
Sponsor: JOURNEY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXELDERM	SULCONAZOLE NITRATE	SOLUTION;TOPICAL	1%	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
N018738-001	EXELDERM	SULCONAZOLE NITRATE	1%	SOLUTION / TOPICAL		RLD, RS	1985-08-30

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	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exelderm	SULCONAZOLE NITRATE	Journey Medical Corporation	5b73e83e-8d3c-4d96-b4f6-9f854430add8	2026-06-08	Adverse reactions	Exact identifier application applno (NDA): 018738 application number: NDA018738 ndc (product): 69489-721
Sulconazole Nitrate	SULCONAZOLE NITRATE	JG Pharma Inc.	cf6f4340-940c-4a61-b675-456e3297d810	2026-06-08	Adverse reactions	Exact identifier application applno (NDA): 018738 application number: NDA018738 ndc (product): 72143-321

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10631-100	Exelderm	sulconazole nitrate	Sun Pharmaceutical Industries, Inc.	NDA	Current
10631-100	Exelderm	sulconazole nitrate	Sun Pharmaceutical Industries, Inc.	NDA	Current
69489-721	Exelderm	Sulconazole Nitrate	Journey Medical Corporation	NDA	Current
69489-721	Exelderm	Sulconazole Nitrate	Journey Medical Corporation	NDA	Current
69489-721	Exelderm	Sulconazole Nitrate	Journey Medical Corporation	NDA	Current
72143-321	Sulconazole Nitrate	Sulconazole Nitrate	JG Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57620	ORIG	2019-02-15
1059	SUPPL	2009-07-13
11313	SUPPL	2009-07-09
16021	SUPPL	2003-06-08
11312	SUPPL	2003-06-08