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N021005-001	SOLARAZE	DICLOFENAC SODIUM	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16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N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`caaa826d4ba7…`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UTC	2026-02	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`011fe1cb6892…`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of this ZIP	2025-12	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`31067a03dcf5…`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UTC	2025-08	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`6a471c1ec25d…`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 5 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	14c1b1a1-bc06-4722-9612-e88ae52272bc	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	1e669fc2-69bf-4439-a336-a103e5b9cafe	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	8825dc2c-3497-455f-b5e1-2aa667291957	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	47ce6fab-be1d-0076-e063-6294a90add63	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	98f94aa2-6bc2-4c07-81c8-63b2c262cf39	2026-01-06	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	c16e7e43-3869-9fef-e053-2995a90a1fdb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	f2b7ea75-738b-54a8-e053-2995a90a00d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	47a7a294-55bb-8d19-e063-6394a90a5440	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	40388047-7fbe-49bf-bed8-e5087bed4e03	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	4a88f136-f7c7-47d7-b85d-8a2f9f118f09	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Safeway, Inc.	196d8af7-739f-4d2c-8c4e-9d33e6d722ab	2025-12-23	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	325213a3-241c-18d2-e063-6394a90a40f7	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	58063c26-86fe-4f03-97ef-51706e5f4054	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	37362eb4-db16-f4ad-e063-6394a90a42aa	2025-12-13	Warnings	Name fallback generic name: DICLOFENAC SODIUM
UP AND UP ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Target Corporation	3a9b32af-a3cd-496b-9698-0421443e0385	2025-12-08	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	4539e9e7-5d82-3b36-e063-6394a90a1396	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Aleve Arthritis Pain Gel	DICLOFENAC SODIUM	Bayer HealthCare LLC	bad675d1-1204-0136-e053-2995a90a994e	2025-12-04	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurobindo Pharma Limited	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	2025-11-19	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	b8072af2-9940-4827-9fbd-de46ad8bf929	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	H E B	027803c5-85ae-4b86-8bd4-e61f8f34d036	2025-11-17	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