Application 021005

Type: NDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOLARAZE	DICLOFENAC SODIUM	GEL;TOPICAL	3%	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
N021005-001	SOLARAZE	DICLOFENAC SODIUM	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021005-001	SOLARAZE	3%	GEL / TOPICAL		RLD	2000-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021005-001	SOLARAZE	3%	GEL / TOPICAL		RLD	2000-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021005-001	SOLARAZE	3%	GEL / TOPICAL		RLD	2000-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021005-001	SOLARAZE	3%	GEL / TOPICAL		RLD	2000-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021005-001	SOLARAZE	3%	GEL / TOPICAL		RLD	2000-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021005-001	SOLARAZE	3%	GEL / TOPICAL		RLD	2000-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021005-001	SOLARAZE	3%	GEL / TOPICAL	AB	RLD, RS	2000-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021005-001	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N021005-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021005-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021005-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021005-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021005-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021005-001	AB	1	`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 12 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	50efc183-dd3e-4eb7-ba5c-c42fd76e0b65	2023-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Proficient Rx LP	f19bf286-f4dd-4491-90c3-9f8713071903	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	CVS Pharmacy	e9ccaf95-582b-4d4d-938f-7577eaa8dffb	2023-11-27	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	e6a1ff58-a541-46f8-9663-eed53b7cf392	2023-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	51756947-e802-4b4d-883e-fd6f22e9a725	2023-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	9df87100-acf5-4b46-93b4-067b470136bd	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	CVS PHARMACY, INC	4808015d-cfee-4f4d-a84b-82099f0b4868	2023-10-04	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	0379c918-1717-40ab-81cc-268116950fd5	2023-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	6a9c3cea-7b46-427d-99af-90c1f290b190	2023-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
equaline arthritis pain relieving	DICLOFENAC SODIUM	United Natural Foods, Inc. dba UNFI	748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d0	2023-08-23	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	2a599579-b2b0-4423-8e30-fe04bf815870	2023-08-11	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	AmerisourceBergen (Good Neighbor Pharmacy) 46122	30e1f589-b322-48b7-9a97-502afe2a1baa	2023-08-09	Warnings	Name fallback generic name: DICLOFENAC SODIUM
equate arthritis pain	DICLOFENAC SODIUM	Wal-Mart Stores Inc	5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b	2023-07-27	Warnings	Name fallback generic name: DICLOFENAC SODIUM
berkley and jensen arthritis pain	DICLOFENAC SODIUM	BJWC	441cf367-b293-47e8-a8fb-32e3314be7de	2023-07-26	Warnings	Name fallback generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	16853c78-493a-4b8b-87b9-97dc927e1c8e	2023-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
CareOne arthritis pain relief	DICLOFENAC SODIUM	American Sales Company	69615972-b593-44fb-ae49-9441d872d84a	2023-06-08	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DG health arthritis pain	DICLOFENAC SODIUM	Dolgencorp Inc	e7f93d8f-df2b-4005-b58d-c6f10ae0e0f3	2023-05-24	Warnings	Name fallback generic name: DICLOFENAC SODIUM
arthritis pain reliever	DICLOFENAC SODIUM	Publix Super Markets Inc	445de976-9a28-4e97-929f-c77aeb21c1fa	2023-05-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
arthritis pain relieving	DICLOFENAC SODIUM	Meijer Distribution Inc	d46a4841-2f86-4e0e-ac79-9b1444ed4f79	2023-05-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
topcare athritis pain reliever	DICLOFENAC SODIUM	Topco Associates LLC	d3e9416d-e13b-4cc7-a663-6df3534b8dbe	2023-05-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0803	DICLOFENAC SODIUM	diclofenac sodium	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0168-0844	DICLOFENAC SODIUM	diclofenac sodium	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
10337-803	Solaraze	diclofenac sodium	PharmaDerm a division of Fougera Pharmaceuticals Inc.	NDA	Current
10337-844	Solaraze	diclofenac sodium	PharmaDerm a division of Fougera Pharmaceuticals Inc.	NDA	Current
10337-844	Solaraze	diclofenac sodium	PharmaDerm a division of Fougera Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80373	SUPPL	2024-11-25
80302	SUPPL	2024-11-22
72637	SUPPL	2022-11-17
72636	SUPPL	2022-11-17
72618	SUPPL	2022-11-15
70713	SUPPL	2022-04-06
70712	SUPPL	2022-04-06
70706	SUPPL	2022-04-06
67381	SUPPL	2021-05-03
67266	SUPPL	2021-04-30
23215	SUPPL	2016-05-18
14147	SUPPL	2016-05-11
4018	SUPPL	2016-05-11
26461	SUPPL	2011-12-14
14146	SUPPL	2011-12-14
26460	SUPPL	2007-06-07
4017	SUPPL	2004-07-28
26459	SUPPL	2004-03-24
21349	ORIG	2003-07-08
35862	SUPPL	2003-05-29
26458	SUPPL	2003-05-29
14145	ORIG	2000-10-16
4016	ORIG	2000-10-16