Application 206655

Type: ANDA
Sponsor: AKORN

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 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
A206655-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2021-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A206655-001	AT

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206655-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2021-01-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206655-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206655-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206655-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206655-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206655-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206655-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206655-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206655-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206655-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206655-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206655-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206655-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206655-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206655-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206655-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206655-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206655-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206655-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206655-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206655-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206655-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206655-001	AT	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206655-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206655-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206655-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206655-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206655-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206655-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206655-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206655-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206655-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206655-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206655-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206655-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206655-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206655-001	AT	1	`a50c72e98297…`

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 2 of 16 · 314 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	REMEDYREPACK INC.	cc8c3125-ee43-40bb-8500-339efa901b8c	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	St. Mary's Medical Park Pharmacy	5f4b69de-8ddd-26c5-e053-2a91aa0ab326	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	c1d87003-f54b-4381-9e11-1c39ea2d9eb3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	081b43f9-f594-4b1e-8564-7dbbea6fa5bd	2026-05-26	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1eb7a7bb-c524-4168-8ade-4601dc11533b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
arthritis pain reliever	DICLOFENAC SODIUM	HyVee Inc	bc74d53d-4142-4391-935b-61b7e353bd65	2026-04-30	Warnings	Name fallback generic name: DICLOFENAC SODIUM
TOPCARE ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Topco Associates LLC	1d6c4c38-3739-4d58-9811-bac09fcbfadb	2026-04-24	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	7e940ce5-0f82-4d07-b507-c644481879c1	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Walgreens	33a37e3d-0463-428c-9169-240eeb77af2b	2026-04-21	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
EQUATE ARTHRITIS PAIN	DICLOFENAC SODIUM	WALMART INC.	d05b5f82-8772-4e01-8eb3-6fa6042f5661	2026-04-20	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	b28e4a68-f396-4c1a-ba38-6a972906b4d0	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	ASCLEMED USA INC.	fd94964b-167b-41b7-a612-8febe9ae0511	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	96f8c42c-db34-43b0-a891-33dd8e39e74f	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	e947653c-6789-4c15-82c9-4b1402f6d6ac	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurolife Pharma LLC	dfb7afdf-5c05-4487-9044-936e151e5ba6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	5d0a4b41-afbf-45e7-bb1c-587d72314ee0	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	15b280a1-4964-4636-833b-3db44044d289	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	Preferred Pharmaceuticals Inc.	937e9ba5-cdad-4e72-a77a-bad699e1b236	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals, Inc.	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM