Application 206493

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	GEL;TOPICAL	3%	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
A206493-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2015-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206493-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206493-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2015-12-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206493-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206493-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206493-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206493-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206493-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206493-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206493-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206493-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206493-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206493-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206493-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206493-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206493-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206493-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206493-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206493-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206493-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206493-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206493-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206493-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206493-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206493-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206493-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206493-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206493-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206493-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206493-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206493-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206493-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206493-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206493-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206493-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206493-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206493-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206493-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206493-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206493-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206493-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206493-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206493-001	AB	1	`e64feba35796…`

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Actavis Pharma, Inc.	74169b2d-ac56-4757-86c4-cdcfcd5f4eb5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206493 application number: ANDA206493 ndc (product): 0472-1783
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	b41335b6-859f-4568-84d2-0d0408415a4e	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206493 application number: ANDA206493
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	b162d65d-b105-4a68-90bb-316b9686267b	2022-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206493 application number: ANDA206493 ndc (product): 76420-261

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-1783	Diclofenac Sodium	Diclofenac Sodium	Actavis Pharma, Inc.	ANDA	Current
0472-1783	Diclofenac Sodium	Diclofenac Sodium	Actavis Pharma, Inc.	ANDA	Current
0472-1783	Diclofenac Sodium	Diclofenac Sodium	Actavis Pharma, Inc.	ANDA	Current
68788-7518	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7518	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
76420-261	Diclofenac Sodium	Diclofenac Sodium	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10574	ORIG	2015-12-07