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 42.

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N021005-001	SOLARAZE	DICLOFENAC SODIUM	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16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 · 42 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
2026-08-18 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N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`caaa826d4ba7…`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UTC	2026-02	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`011fe1cb6892…`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of this ZIP	2025-12	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`31067a03dcf5…`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UTC	2025-08	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`6a471c1ec25d…`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of this ZIP	2025-03	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`fd3edfee7708…`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…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`

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 3 of 14 · 275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	4ddd7e34-e5f4-8f05-e063-6294a90a70aa	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	663a3dbc-a631-4046-8852-ec619c41c81d	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DirectRx	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Direct_Rx	946b3799-2d56-12a5-e053-2a95a90aeba0	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Redpharm Drug	4cd2e51b-2019-6eb6-e063-6294a90ad7ef	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Edenbridge Pharmaceuticals LLC.	bd25a2b1-a4d5-4893-97d1-efdcd414a97d	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	337c2253-34c1-4611-88c9-d558507255a2	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	fae53d24-acf1-4250-888d-b8d965ffc3d3	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	942b4a76-1029-4cd7-9def-531ed33f3053	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	06862cf2-9537-6661-e063-6294a90a2084	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	03c4f06f-6a49-4404-bf3b-0aafa33c81ef	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Northwind Health Company, LLC	4dde6e36-7540-1cc3-e063-6294a90a3941	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Rugby Laboratories	95f3c70c-eded-4d24-b9b0-cfa0b7902d6e	2026-02-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6aab6c1f-9b02-4101-b7c8-ab7a55704320	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	11e88ced-cdcf-4101-9297-c4c3dde9d089	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	99f1e69e-02cf-49c2-83af-3cccbbea4215	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	0cefb675-c54e-44eb-b35c-38354b77eddd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	74011b00-7e2e-40a7-ab30-c05a20559814	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	e9ec5462-939a-4022-8946-5d81869a6277	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Umedica Laboratories USA Inc.	0e5c6669-390f-4c32-b9b8-13ed3c517462	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM

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