Application 075152

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	50MG	No	No

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

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
A075152-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL			1998-11-27

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075152-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	1998-11-27	`f41ea6bd6efb…`

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 3 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Leading Pharma, LLC	698690a7-4978-4457-b123-0a670bbab481	2025-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
diclofenac potassium	DICLOFENAC POTASSIUM	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d64537c8-e397-4d17-b95c-3092668260aa	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	PD-Rx Pharmaceuticals, Inc.	08e41a9d-644c-4ac6-aba3-38d7c3f36d36	2025-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Marlex Pharmaceuticals, Inc.	30c7197b-7110-d8a7-e063-6394a90addfb	2025-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Coupler LLC	2eead069-f954-abb2-e063-6394a90a14ff	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	NuCare Pharmaceuticals,Inc.	ffc41543-a353-cade-e053-6294a90a99fb	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium
Diclofenac potassium	DICLOFENAC POTASSIUM	Camber Pharmaceuticals, Inc.	9261a9d6-f772-41a2-ac99-8608c04c355b	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	69ab6f91-5770-480c-8bd1-8c1f1f8bfdb5	2025-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	8c54e404-2dbd-49cd-8235-b2a708bae563	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Teva Pharmaceuticals USA, Inc.	77b60a0c-e49a-4ad4-abb1-b662c24ab782	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Archis Pharma LLC	0d83cab3-c698-4763-9e77-27d72ba94e30	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Advanced Rx of Tennessee, LLC	295d167c-eb56-8e14-e063-6394a90ad325	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Advanced Rx of Tennessee, LLC	295d5dab-8890-d76e-e063-6394a90ad402	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM, FILM COATED	Cintex Services, LLC	0cdea9d3-fada-b00e-e063-6394a90ad5d9	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Cambia	DICLOFENAC POTASSIUM	Assertio Therapeutics, Inc.	d249ced1-4ca0-4f57-adcb-23440f58f659	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Aurobindo Pharma Limited	7efdbe23-503a-4f38-a0b6-c003033f0de7	2024-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals, Inc.	26a8f723-2a8e-8a5a-e063-6394a90a7bae	2024-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals, Inc.	3da9e463-1b2f-54c0-e054-00144ff88e88	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
LOFENA	DICLOFENAC POTASSIUM	Carwin Pharmaceutical Associates, LLC	49bd64cc-5edb-44f2-8e24-1249f6a76663	2024-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	Leading Pharma, LLC	9dd418b2-4b0e-498c-b453-f580c69ddc6d	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM generic name: DICLOFENAC POTASSIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8539	ORIG	1998-11-27