Application 210986

Type: ANDA
Sponsor: ENCUBE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	GEL;TOPICAL	1%	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
A210986-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2020-01-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`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 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Sportpharm LLC	391d9d0b-74b7-4359-aea0-d3bb8c8d3cd1	2026-07-10	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	Preferred Pharmaceuticals, Inc.	aee20924-79ab-400e-b9b6-418978914654	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 68788-7772
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Sportpharm LLC	a133d18e-981d-43b7-bef1-7869f7c7d9a7	2026-02-09	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Asclemed USA, Inc.	6952a221-17fd-4592-8edc-ff3699743533	2026-01-13	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	81f78685-c416-48b5-8840-eef03a66bc28	2026-01-12	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM 1%	SOLA Pharmaceuticals	bdbe3f24-3015-1f32-e053-2995a90aa665	2025-12-08	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 70512-106
Diclofenac Sodium Topical 1%	DICLOFENAC SODIUM	YYBA CORP	043df5d2-6f3e-311f-e063-6294a90a23d7	2025-11-10	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Dr. Reddy's Laboratories Inc.	c88b2512-0255-658d-252a-c006275159b0	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 43598-885
Arthritis Pain	DICLOFENAC SODIUM TOPICAL GEL, 1%	Strategic Sourcing Services, LLC	5de514ee-fd59-ef95-8dc3-16e34321572b	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Chain Drug Marketing Association INC	625d21e8-0731-1157-30fe-9f9868ff8dc4	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 63868-730
Diclofenac Sodium Topical Gel 1%	DICLOFENAC SODIUM TOPICAL GEL, 1%	Walgreens Company	40d0553b-a97a-1315-3fca-8ef38611505e	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 0363-7065
Arthritis Pain	DICLOFENAC SODIUM TOPICAL GEL, 1%	Discount Drug Mart, Inc.	ae1ebe9c-b1fa-6762-949e-cb83b33319a2	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium Topical Gel 1%	DICLOFENAC SODIUM TOPICAL GEL, 1%	Kroger Company	2081371d-436a-16fc-db80-ced6288f52bc	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 30142-025
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	GERI-CARE PHARMACEUTICALS CORP	91fc618a-edd0-5944-083f-c00075476f55	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 57896-140
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Encube Ethicals, Inc.	6e8c45e1-8cd4-4ff7-a758-f9d2ed37e593	2025-10-01	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 21922-044
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	BluePoint Laboratories	274543d2-a9a6-1e37-e063-6394a90ae3f1	2025-08-11	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Dr. Reddy's Laboratories Inc.	03abebd6-426a-9d05-3dff-196477389430	2025-05-05	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 43598-977
Diclofenac Sodium Gel	DICLOFENAC SODIUM GEL	Direct_Rx	fce9b3eb-ae79-a090-e053-6294a90ad20e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	ad193f94-f8d0-8482-e053-2995a90a35a4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986 ndc (product): 68071-2239
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f3d27ae6-1259-5375-e053-2995a90a572d	2024-12-31	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-7065	Diclofenac Sodium Topical Gel 1%	diclofenac sodium topical gel, 1%	Walgreens Company	ANDA	Current
0363-7065	Diclofenac Sodium Topical Gel 1%	diclofenac sodium topical gel, 1%	Walgreens Company	ANDA	Current
0363-7065	Diclofenac Sodium Topical Gel 1%	diclofenac sodium topical gel, 1%	Walgreens Company	ANDA	Current
21922-009	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Encube Ethicals Private Limited	ANDA	Current
21922-009	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Encube Ethicals Private Limited	ANDA	Current
21922-044	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-044	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-044	Diclofenac Sodium	diclofenac sodium topical gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-044	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Encube Ethicals Private Limited	ANDA	Current
30142-025	Diclofenac Sodium Topical Gel 1%	Diclofenac sodium topical gel, 1%	Kroger Company	ANDA	Current
30142-025	Diclofenac Sodium Topical Gel 1%	Diclofenac sodium topical gel, 1%	Kroger Company	ANDA	Current
30142-025	Diclofenac Sodium Topical Gel 1%	Diclofenac sodium topical gel, 1%	Kroger Company	ANDA	Current
30142-025	Diclofenac Sodium Topical Gel 1%	Diclofenac sodium topical gel, 1%	Kroger Company	ANDA	Current
43598-885	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-885	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-885	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-977	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-977	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-977	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	Dr. Reddy's Laboratories Inc.	ANDA	Current
53002-4642	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-863	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Quality Care Products, LLC	ANDA	Current
57896-140	DICLOFENAC SODIUM	diclofenac sodium topical gel, 1%	GERI-CARE PHARMACEUTICALS CORP	ANDA	Current
63868-730	DICLOFENAC SODIUM	Diclofenac Sodium topical gel, 1%	Chain Drug Marketing Association INC	ANDA	Current
68071-2239	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2239	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7772	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7772	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7772	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Preferred Pharmaceuticals, Inc.	ANDA	Current
70512-106	Diclofenac Sodium	Diclofenac Sodium 1%	SOLA Pharmaceuticals	ANDA	Current
70512-106	Diclofenac Sodium	Diclofenac Sodium 1%	SOLA Pharmaceuticals	ANDA	Current
70512-106	Diclofenac Sodium	Diclofenac Sodium 1%	SOLA Pharmaceuticals	ANDA	Current
70518-2813	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	REMEDYREPACK INC.	ANDA	Current
70518-2813	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	REMEDYREPACK INC.	ANDA	Current
70518-2813	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	REMEDYREPACK INC.	ANDA	Current
70518-2813	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	REMEDYREPACK INC.	ANDA	Current
70677-0143	Arthritis Pain	diclofenac sodium topical gel, 1%	Strategic Sourcing Services, LLC	ANDA	Current
71205-552	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Proficient Rx LP	ANDA	Current
72559-020	Curist Arthritis Relief	Diclofenac Sodium	Little Pharma, Inc.	ANDA	Current
73715-005	Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1% (NSAID)	Mohnark Pharmaceuticals Inc.	ANDA	Current
73715-005	Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1% (NSAID)	Mohnark Pharmaceuticals Inc.	ANDA	Current
76420-091	Diclofenac Sodium	Diclofenac Sodium Topical Gel, 1%,	Asclemed USA, Inc.	ANDA	Current
82226-020	ValcoPrep-100	diclofenac sodium, isopropyl alcohol	Plum Valley Pharma LLC	ANDA	Current
82226-020	ValcoPrep-100	diclofenac sodium, isopropyl alcohol	Plum Valley Pharma LLC	ANDA	Current
82226-020	ValcoPrep-100	diclofenac sodium, isopropyl alcohol	Plum Valley Pharma LLC	ANDA	Current