Application 210893

Type: ANDA
Sponsor: PERRIGO UK FINCO

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
A210893-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2018-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210893-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210893-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2018-07-27	`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	A210893-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210893-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210893-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210893-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210893-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210893-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210893-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210893-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210893-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210893-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210893-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210893-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210893-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210893-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210893-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210893-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210893-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210893-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210893-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210893-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210893-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210893-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210893-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210893-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210893-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210893-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210893-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210893-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210893-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210893-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210893-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210893-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210893-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210893-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210893-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210893-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210893-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210893-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210893-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210893-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6aab6c1f-9b02-4101-b7c8-ab7a55704320	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210893 application number: ANDA210893 ndc (product): 70518-2526
diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	bf372e32-0902-447f-9673-00a3fcf0064c	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210893 application number: ANDA210893
diclofenac sodium	DICLOFENAC SODIUM	Padagis Israel Pharmaceuticals Ltd	3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b8	2024-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210893 application number: ANDA210893 ndc (product): 45802-111
diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	8721da56-0f8a-5903-e053-2991aa0a61b5	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210893 application number: ANDA210893 ndc (product): 68071-4859
diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	16853c78-493a-4b8b-87b9-97dc927e1c8e	2023-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210893 application number: ANDA210893 ndc (product): 63629-2526
diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	67e384c6-8476-4aad-b967-241335538d56	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210893 application number: ANDA210893 ndc (product): 71205-692

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-111	diclofenac sodium	diclofenac sodium	Perrigo New York Inc	ANDA	Current
45802-111	diclofenac sodium	diclofenac sodium	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-111	diclofenac sodium	diclofenac sodium	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-111	diclofenac sodium	diclofenac sodium	Perrigo New York Inc	ANDA	Current
63629-2526	diclofenac sodium	diclofenac sodium	Bryant Ranch Prepack	ANDA	Current
63629-2526	diclofenac sodium	diclofenac sodium	Bryant Ranch Prepack	ANDA	Current
63629-2526	diclofenac sodium	diclofenac sodium	Bryant Ranch Prepack	ANDA	Current
68071-4859	diclofenac sodium	diclofenac sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4859	diclofenac sodium	diclofenac sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8237	diclofenac sodium	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2526	diclofenac sodium	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
70518-2526	diclofenac sodium	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
70518-2526	diclofenac sodium	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
70518-2526	diclofenac sodium	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
70518-2526	diclofenac sodium	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
71205-692	diclofenac sodium	diclofenac sodium	Proficient Rx LP	ANDA	Current