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N021005-001	SOLARAZE	DICLOFENAC SODIUM	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16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N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`caaa826d4ba7…`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UTC	2026-02	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`011fe1cb6892…`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of this ZIP	2025-12	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`31067a03dcf5…`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UTC	2025-08	N021005-001	SOLARAZE	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2000-10-16	`6a471c1ec25d…`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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARTHRITIS PAIN RELIEVING	DICLOFENAC SODIUM	Meijer, Inc.	5cc570c6-2585-4d1a-9352-b1161458af9a	2025-11-17	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	PHOENIX RX LLC	41472cca-278b-934b-e063-6294a90aaf5d	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	4382cc15-8978-4f3b-e063-6394a90a9ecb	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Topical 1%	DICLOFENAC SODIUM	YYBA CORP	043df5d2-6f3e-311f-e063-6294a90a23d7	2025-11-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0b4fd47f-903c-097b-e063-6394a90a49ab	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Lupin Pharmaceuticals, Inc.	609c5344-9c97-4fa8-ad53-d0f622ce64ec	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	GLENMARK PHARMACEUTICALS INC., USA	dab3ae60-0135-43b3-a1d0-8752720af82a	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	41da2e11-58c7-9622-e063-6394a90a9fdb	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	BluePoint Laboratories	feb1541a-de83-47dd-be03-c43376527318	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVING	DICLOFENAC SODIUM	Walgreen Company	b1850a16-54f1-4210-abdf-26414da8b3d9	2025-09-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
FOSTER AND THRIVE ARTHRITIS PAIN	DICLOFENAC SODIUM	Strategic Sourcing Services LLC	f9f4e55f-ffad-4df7-9b3c-1e7c3a3723c1	2025-09-27	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DG HEALTH ARTHRITIS PAIN	DICLOFENAC SODIUM	Dolgencorp Inc	6479e4bb-0790-483e-bfe3-a54d549aa5d2	2025-09-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	3e15c3db-5245-76fb-e063-6394a90a814e	2025-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	4c5b722e-0d1a-48e9-87c8-9b370b8ced46	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	4e97c685-628a-4b83-ba9e-2d3caf65542b	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	3d71f76d-bb23-7251-e063-6394a90aa9d8	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Best Choice (Valu Merchandisers Company)	4ea809a9-387a-4193-a176-d8b22eaa55e6	2025-08-21	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	ca0f9295-4933-48d6-9387-90345fd5dcaa	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Rising Pharma Holdings, Inc.	3330ea92-fc9d-4541-b378-be399b0995d3	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	3a4f7301-aa1c-9064-e063-6294a90a6eb4	2025-07-21	Boxed warning, Warnings, Adverse reactions	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