Application 075463

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	50MG	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
A075463-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1999-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075463-001	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	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1999-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1999-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1999-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1999-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075463-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1999-07-26	`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	A075463-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075463-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075463-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075463-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075463-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075463-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075463-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075463-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075463-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075463-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075463-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075463-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075463-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075463-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075463-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075463-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075463-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075463-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075463-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075463-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075463-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075463-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075463-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075463-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075463-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075463-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075463-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075463-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075463-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075463-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075463-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075463-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075463-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075463-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075463-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075463-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075463-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075463-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075463-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075463-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Marlex Pharmaceuticals, Inc.	30c7197b-7110-d8a7-e063-6394a90addfb	2025-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075463 application number: ANDA075463
Diclofenac Potassium	DICLOFENAC POTASSIUM	Archis Pharma LLC	0d83cab3-c698-4763-9e77-27d72ba94e30	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075463 application number: ANDA075463 ndc (product): 72819-151
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals, Inc.	26a8f723-2a8e-8a5a-e063-6394a90a7bae	2024-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075463 application number: ANDA075463

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2474	Diclofenac Potassium	diclofenac potassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2474	Diclofenac Potassium	diclofenac potassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2474	Diclofenac Potassium	diclofenac potassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2474	Diclofenac Potassium	diclofenac potassium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2474	Diclofenac Potassium	diclofenac potassium	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-1535	Diclofenac Potassium	diclofenac potassium	A-S Medication Solutions	ANDA	Current
50090-1535	Diclofenac Potassium	diclofenac potassium	A-S Medication Solutions	ANDA	Current
63629-7969	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
63629-7969	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
67296-1746	Diclofenac Potassium	diclofenac potassium	RedPharm Drug, Inc.	ANDA	Current
67296-1746	Diclofenac Potassium	diclofenac potassium	RedPharm Drug, Inc.	ANDA	Current
68071-4042	Diclofenac Potassium	diclofenac potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2185	Diclofenac Potassium	diclofenac potassium	REMEDYREPACK INC.	ANDA	Current
70518-2185	Diclofenac Potassium	diclofenac potassium	REMEDYREPACK INC.	ANDA	Current
70518-2185	Diclofenac Potassium	diclofenac potassium	REMEDYREPACK INC.	ANDA	Current
70518-2185	Diclofenac Potassium	diclofenac potassium	REMEDYREPACK INC.	ANDA	Current
71335-0369	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
71335-0369	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
71335-0369	Diclofenac Potassium	diclofenac potassium	Bryant Ranch Prepack	ANDA	Current
72789-051	Diclofenac Potassium	diclofenac potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-051	Diclofenac Potassium	diclofenac potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-051	Diclofenac Potassium	diclofenac potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-051	Diclofenac Potassium	diclofenac potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72819-151	Diclofenac Potassium	diclofenac potassium	Archis Pharma LLC	ANDA	Current
72819-151	Diclofenac Potassium	diclofenac potassium	Archis Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30893	ORIG	1999-07-26