Application 076201

Type: ANDA
Sponsor: DEXCEL LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, EXTENDED RELEASE;ORAL	100MG	No	Yes

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
A076201-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076201-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`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	A076201-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076201-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076201-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076201-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076201-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076201-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076201-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076201-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076201-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076201-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076201-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076201-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076201-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076201-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076201-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076201-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076201-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076201-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076201-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076201-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076201-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076201-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076201-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076201-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076201-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076201-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076201-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076201-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076201-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076201-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076201-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076201-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076201-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076201-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076201-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076201-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076201-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076201-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076201-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076201-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	4ddd7e34-e5f4-8f05-e063-6294a90a70aa	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201
Diclofenac Sodium	DICLOFENAC SODIUM	Edenbridge Pharmaceuticals LLC.	bd25a2b1-a4d5-4893-97d1-efdcd414a97d	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	0d1d19e5-4ffe-af95-e063-6394a90a7abf	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, LLC.	26e44aa5-cfcd-f10b-e063-6394a90a4dcf	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2170	Diclofenac Sodium	Diclofenac Sodium	Lannett Company, Inc.	ANDA	Current
0527-2170	Diclofenac Sodium	Diclofenac Sodium	Lannett Company, Inc.	ANDA	Current
0527-2170	Diclofenac Sodium	Diclofenac Sodium	Lannett Company, Inc.	ANDA	Current
0527-2170	Diclofenac Sodium	Diclofenac Sodium	Lannett Company, Inc.	ANDA	Current
0527-2170	Diclofenac Sodium	Diclofenac Sodium	Lannett Company, Inc.	ANDA	Current
0591-0676	Diclofenac Sodium	Diclofenac Sodium	Actavis Pharma, Inc.	ANDA	Current
10544-928	Diclofenac Sodium	Diclofenac Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
50090-1185	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50436-0676	Diclofenac Sodium	Diclofenac Sodium	Unit Dose Services	ANDA	Current
55700-246	Diclofenac Sodium	Diclofenac Sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-058	Diclofenac Sodium	Diclofenac Sodium	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-468	DICLOFENAC SODIUM	DICLOFENAC SODIUM	Direct RX	ANDA	Current
63187-475	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
66267-709	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-709	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3325	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9523	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1903	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1903	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1903	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1903	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1903	Diclofenac Sodium	Diclofenac Sodium	REMEDYREPACK INC.	ANDA	Current
70934-027	Diclofenac Sodium	Diclofenac Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-027	Diclofenac Sodium	Diclofenac Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0170	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1238	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1238	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1238	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1238	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current