Application 075492

Type: ANDA
Sponsor: VPNA

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	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
A075492-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075492-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`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	A075492-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075492-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075492-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075492-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075492-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075492-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075492-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075492-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075492-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075492-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075492-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075492-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075492-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075492-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075492-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075492-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075492-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075492-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075492-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075492-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075492-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075492-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075492-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075492-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075492-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075492-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075492-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075492-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075492-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075492-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075492-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075492-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075492-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075492-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075492-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075492-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075492-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075492-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075492-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075492-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Oceanside Pharmaceuticals	c48113e0-9f1e-4086-b18f-3204c0d2a689	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492 ndc (product): 68682-103
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	d70fcd8e-a72b-41ef-ac26-e0f2f279f062	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492 ndc (product): 63187-994
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	49013aad-475c-4efb-84c6-15a5d4664fbf	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492 ndc (product): 71335-0648
Diclofenac Sodium ER	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	ecaa39b8-067c-80d7-e053-2a95a90a7354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492 ndc (product): 80425-0210
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	abacf60f-0410-e6da-e053-2995a90a413c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492 ndc (product): 68071-2223
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	d9698809-4887-4514-aa28-0066355ef908	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492 ndc (product): 50090-4172

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
50090-4172	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4172	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4172	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4172	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
60760-264	Diclofenac Sodium	Diclofenac Sodium	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-608	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECTRX	ANDA	Current
61919-608	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECTRX	ANDA	Current
61919-608	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECTRX	ANDA	Current
63187-994	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
63187-994	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
68071-2223	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2223	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4158	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4158	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4158	Diclofenac Sodium	Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68682-103	Diclofenac Sodium	Diclofenac Sodium	Oceanside Pharmaceuticals	ANDA	Current
68682-103	Diclofenac Sodium	Diclofenac Sodium	Oceanside Pharmaceuticals	ANDA	Current
68682-103	Diclofenac Sodium	Diclofenac Sodium	Oceanside Pharmaceuticals	ANDA	Current
68682-103	Diclofenac Sodium	Diclofenac Sodium	Oceanside Pharmaceuticals	ANDA	Current
68682-103	Diclofenac Sodium	Diclofenac Sodium	Oceanside Pharmaceuticals	ANDA	Current
68788-6388	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6388	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6388	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6388	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6388	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0648	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0648	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0648	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
80425-0210	Diclofenac Sodium	Diclofenac Sodium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22476	ORIG	2000-02-11
8691	ORIG	2000-02-11