Application 203818

Type: ANDA
Sponsor: TARO

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
A203818-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203818-001	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.

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`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	A203818-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203818-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203818-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203818-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203818-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203818-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203818-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203818-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203818-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203818-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203818-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203818-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203818-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203818-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203818-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203818-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203818-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203818-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203818-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203818-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203818-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203818-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203818-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203818-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203818-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203818-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203818-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203818-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203818-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203818-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203818-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203818-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203818-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203818-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203818-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203818-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203818-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203818-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203818-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203818-001	AT	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 · 10 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.	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818 ndc (product): 68788-7715
Diclofenac Sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	d349d286-b462-4f8f-aa39-6173653175d6	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818 ndc (product): 70518-2811
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DirectRx	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818 ndc (product): 72189-319
Diclofenac Sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	fae53d24-acf1-4250-888d-b8d965ffc3d3	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818 ndc (product): 51672-1358
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	5508f80d-5f11-4959-8e42-9055f0169cfc	2025-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Direct_Rx	f80b0b95-f4da-2d6c-e053-6294a90acf92	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0803345d-7811-bc21-e063-6394a90aa661	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	0379c918-1717-40ab-81cc-268116950fd5	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818 ndc (product): 71205-579
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b0f9e649-6651-406f-a9fe-157fe04d9d27	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818 ndc (product): 71205-062

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-118	Diclofenac Sodium	Diclofenac Sodium	Medsource Pharmaceuticals	ANDA	Current
50436-0002	Diclofenac sodium	diclofenac sodium	Unit Dose Services	ANDA	Current
51672-1358	Diclofenac Sodium	Diclofenac Sodium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1358	Diclofenac Sodium	Diclofenac Sodium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1358	Diclofenac Sodium	Diclofenac Sodium	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55700-966	Diclofenac Sodium	Diclofenac Sodium	Quality Care Products, LLC	ANDA	Current
55700-966	Diclofenac Sodium	Diclofenac Sodium	Quality Care Products, LLC	ANDA	Current
60760-296	Diclofenac Sodium	Diclofenac Sodium	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-296	Diclofenac Sodium	Diclofenac Sodium	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-392	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
61919-392	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
63187-725	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
63187-725	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
68788-7225	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7225	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7225	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7225	Diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7715	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7715	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7715	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2811	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2811	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2811	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2811	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
71085-002	Diclofenac sodium	diclofenac sodium	IPG PHARMACEUTICALS, INC.	ANDA	Current
71085-002	Diclofenac sodium	diclofenac sodium	IPG PHARMACEUTICALS, INC.	ANDA	Current
71205-062	Diclofenac sodium	diclofenac sodium	Proficient Rx LP	ANDA	Current
71205-062	Diclofenac sodium	diclofenac sodium	Proficient Rx LP	ANDA	Current
71205-062	Diclofenac sodium	diclofenac sodium	Proficient Rx LP	ANDA	Current
71205-579	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
71205-579	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
71248-003	DiThol	diclofenac sodium/menthol	Fortus Pharma, LLC	ANDA	Current
71905-300	DiMentho	Diclofenac Sodium 1.5% Solution, Menthol 10% Topical Liquid, and Kinesiology Tape	Levins Pharmaceuticals, LLC	ANDA	Current
72189-319	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DirectRx	ANDA	Current
73272-301	Diclostream	Diclofenac Sodium 1.5% Solution and Menthol 10% Topical Liquid	Upstream Pharma, LLC	ANDA	Current
80175-1358	Diclofenac Sodium	Diclofenac Sodium	Central Packaging	ANDA	Current
80175-1358	Diclofenac Sodium	Diclofenac Sodium	Central Packaging	ANDA	Current
80175-1358	Diclofenac Sodium	Diclofenac Sodium	Central Packaging	ANDA	Current