Application 074514

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	50MG	No	No
002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074514-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB		1996-03-26
A074514-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		1996-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074514-001	AB
A074514-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074514-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074514-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074514-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074514-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074514-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074514-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074514-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074514-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074514-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074514-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074514-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074514-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074514-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074514-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074514-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074514-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074514-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074514-002	AB	1	`74a2ff9319b5…`

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	Golden State Medical Supply, Inc.	c1d87003-f54b-4381-9e11-1c39ea2d9eb3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	663a3dbc-a631-4046-8852-ec619c41c81d	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	47793dca-5e9e-44ee-8e66-5e42e1831b1e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	b74be49d-74ff-491b-962b-0edd3a57cbc9	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	87d5a720-f154-4c4b-b2d4-0ae58455dda0	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	f5b4e308-c156-4865-95ee-1a8e267535ba	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Inflatherm	DICLOFENAC SODIUM AND MENTHOL / CAMPHOR GEL	V2 Pharma, LLC	b62f4306-8dbd-4501-8b1e-9aa78f9aee06	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 72835-701
Diclofenac Sodium	DICLOFENAC SODIUM	Actavis Pharma, Inc.	a57b897e-0cbe-4ac3-969f-b00357a0cfa8	2021-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	77c3cb56-c071-4d92-a0d6-022417a27de4	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e4af374a-1281-46af-a0a9-48820db6c947	2018-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514 ndc (product): 71610-068

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69329-335	DermasilkRx DicloPak	diclofenac sodium delayed release tablets, capsaicin cream	Patchwerx Labs, Inc.	ANDA	Current
70859-004	NuDiclo TabPak	DICLOFENAC SODIUM, Capsaicin	Nucare Pharmaceuticals Inc	ANDA	Current
70859-004	NuDiclo TabPak	DICLOFENAC SODIUM, Capsaicin	Nucare Pharmaceuticals Inc	ANDA	Current
70859-004	NuDiclo TabPak	DICLOFENAC SODIUM, Capsaicin	Nucare Pharmaceuticals Inc	ANDA	Current
70859-004	NuDiclo TabPak	DICLOFENAC SODIUM, Capsaicin	Nucare Pharmaceuticals Inc	ANDA	Current
70859-033	NuDroxiPAK DSDR-50	Diclofenac Sodium, Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals, Inc.	ANDA	Current
70859-033	NuDroxiPAK DSDR-50	Diclofenac Sodium, Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals, Inc.	ANDA	Current
70859-034	NuDroxiPAK DSDR-75	Diclofenac Sodium, Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-034	NuDroxiPAK DSDR-75	Diclofenac Sodium, Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-046	DFS 75mg DR/MS 25%/MENTH 6%/CAP 0.025% PAK	Diclofenac Sodium, Methyl Salicylate, Menthol, Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-046	DFS 75mg DR/MS 25%/MENTH 6%/CAP 0.025% PAK	Diclofenac Sodium, Methyl Salicylate, Menthol, Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-687	Diclofenac Sodium	Diclofenac Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71610-068	Diclofenac Sodium	Diclofenac Sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72835-401	Inflatherm	Diclofenac Sodium and Trolamine Salicylate	V2 Pharma	ANDA	Current
72835-701	Inflatherm	Diclofenac Sodium and Menthol / Camphor Gel	V2 Pharma, LLC	ANDA	Current
72835-701	Inflatherm	Diclofenac Sodium and Menthol / Camphor Gel	V2 Pharma, LLC	ANDA	Current
72835-701	Inflatherm	Diclofenac Sodium and Menthol / Camphor Gel	V2 Pharma, LLC	ANDA	Current