Application 206715

Type: ANDA
Sponsor: RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	SOLUTION;TOPICAL	1.5%	No	No

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
A206715-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2017-08-07

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2017-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2017-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A206715-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206715-001	AT	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 14 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	6a9c3cea-7b46-427d-99af-90c1f290b190	2023-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium 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 brand name: Diclofenac Sodium 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 brand name: diclofenac sodium 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
Diclofenac Sodium	DICLOFENAC	Proficient Rx LP	f4da38af-c5bd-4d4a-a6f3-c2933f223809	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC	Bryant Ranch Prepack	e5f8284a-1aa9-4a36-a6ad-fa153c613f34	2023-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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
good sense arthritis pain	DICLOFENAC SODIUM	L. Perrigo Company	7b32b9e4-6502-4fa3-808f-3bef9525b6a1	2023-05-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	A-S Medication Solutions	58178f0d-3960-48e3-91ba-150f691be241	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
arthritis pain reliever	DICLOFENAC SODIUM	H E B	e8fe4a89-586d-461c-b242-b68e38a508b4	2023-03-09	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Quality Care Products LLC	94422b85-28ed-477f-853a-71d1d6cf17d5	2023-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Proficient Rx LP	73a46413-ecbc-4453-814d-bec955b375d2	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	b41335b6-859f-4568-84d2-0d0408415a4e	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium 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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-983	Diclofenac Sodium Topical Solution	Diclofenac Sodium	medsource pharmaceuticals	ANDA	Current
50742-308	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-308	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-308	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-308	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-308	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Ingenus Pharmaceuticals, LLC	ANDA	Current
68788-7151	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7151	Diclofenac Sodium Topical Solution	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
69420-9001	CapsFenac Pak	diclofenac sodium and capsaicin	SA3, LLC	ANDA	Current
69420-9001	CapsFenac Pak	diclofenac sodium and capsaicin	SA3, LLC	ANDA	Current