Application 206298

Type: ANDA
Sponsor: TARO

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 1.

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
A206298-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206298-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206298-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206298-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206298-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206298-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206298-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206298-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206298-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206298-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206298-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206298-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206298-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206298-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206298-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206298-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206298-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206298-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206298-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206298-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206298-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206298-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206298-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206298-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206298-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206298-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206298-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206298-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206298-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206298-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206298-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206298-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206298-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206298-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206298-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206298-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206298-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206298-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206298-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206298-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206298-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206298-001	AB	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	71a823c4-9c88-474d-b525-276f9e7808aa	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Direct_Rx	946b3799-2d56-12a5-e053-2a95a90aeba0	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 72189-040
Diclofenac sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 51672-1363
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	81bfeada-6589-4528-bea5-059ab0fabb43	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 68788-8236
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7264-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 80425-0235
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	22f4b8aa-902f-a860-e063-6394a90ada26	2024-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b98d921a-2ee7-4770-ac21-d845b2dcc11c	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 71205-538
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	d4b81a74-6926-4715-bf90-aec026cff2b4	2022-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 76420-275

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45861-063	Diclofenac sodium	diclofenac sodium	Pharmaceutica North America, Inc	ANDA	Current
51672-1363	Diclofenac sodium	diclofenac sodium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1363	Diclofenac sodium	diclofenac sodium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55700-980	Diclofenac sodium	diclofenac sodium	Quality Care Products, LLC	ANDA	Current
68788-7546	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7546	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8236	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3464	Diclofenac sodium	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
71085-003	Diclofenac sodium	diclofenac sodium	IPG PHARMACEUTICALS, INC.	ANDA	Current
71205-538	Diclofenac sodium	diclofenac sodium	Proficient Rx LP	ANDA	Current
72189-040	DICLOFENAC SODIUM	DICLOFENAC SODIUM	Direct_Rx	ANDA	Current
76420-275	Diclofenac sodium	diclofenac sodium	Asclemed USA, Inc.	ANDA	Current
80425-0235	Diclofenac Sodium	Diclofenac Sodium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32792	ORIG	2016-05-04