Application 075281

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075281-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB		2002-02-12
A075281-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2002-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075281-002	AB
A075281-003	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 · 82 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	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075281-003	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A075281-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075281-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075281-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075281-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075281-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075281-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075281-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075281-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075281-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075281-003	AB	1	`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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	6e6a6f98-5517-4f67-9a6a-71019ba2d773	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Northwind Health Company, LLC	4dde6e36-7540-1cc3-e063-6294a90a3941	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	f92576d7-3ad9-43a3-8b10-3a29fbf712a4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	6c57e330-ebbe-4165-84a8-4844b2f0097e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	3487033c-7c62-4034-8718-73a7c49b26a0	2025-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6280	Diclofenac Sodium	diclofenac sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6280	Diclofenac Sodium	diclofenac sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6281	Diclofenac Sodium	diclofenac sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6281	Diclofenac Sodium	diclofenac sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-224	Diclofenac Sodium	diclofenac sodium	Mylan Institutional Inc.	ANDA	Current
51079-224	Diclofenac Sodium	diclofenac sodium	Mylan Institutional Inc.	ANDA	Current
51079-466	Diclofenac Sodium	diclofenac sodium	Mylan Institutional Inc.	ANDA	Current
68788-9185	Diclofenac Sodium	diclofenac sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current