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 2 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	Nivagen Pharmaceuticals, Inc.	eb52a015-23cd-40f6-bf83-6749fc34947c	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM, FILM COATED	INA Pharmaceutics Inc,	6c703075-b9a3-42de-87f6-fd1e1ef4b2e3	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Chartwell RX, LLC	3a837a3e-10b2-4256-b515-80c863318ccb	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	NIVAGEN PHARMACEUTICALS, INC.	1f06a404-07c3-4414-8c5c-357c01d6ccb3	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium
Diclofenac Potassium	DICLOFENAC POTASSIUM	SOLA Pharmaceuticals, LLC	26bf3a4a-42c6-cb59-e063-6394a90abd8b	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Doc Rx	6394ab5f-b3ff-4397-97eb-ff92485c5ec0	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Phoenix RX LLC	3fd418ac-49f6-d520-e063-6394a90afbd8	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Ingenus Pharmaceuticals, LLC	6926444f-0dca-4aeb-812e-755a83b149f4	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM, FILM COATED	Golden State Medical Supply, Inc.	26d0ed73-b7a6-cbd8-e063-6394a90a9a31	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Trifluent Pharma LLC	8fdb1036-c0d8-4288-ac37-6512b05672ef	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM, FILM COATED	Happy Robin, LLC	3f91023f-9db9-88ba-e063-6394a90abd44	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	INA Pharmaceutics Inc	5ecd99fe-cb74-4a65-9636-2aefd2416ece	2025-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac potassium	DICLOFENAC POTASSIUM	TEVA PHARMACEUTICALS, INC.	d9685883-9d0b-81da-e053-2a95a90ab8d8	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac potassium generic name: DICLOFENAC POTASSIUM
ZIPSOR	DICLOFENAC POTASSIUM	Assertio Therapeutics, Inc.	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	2025-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM, FILM COATED	Amici Pharma, Inc	c4ce1497-9cb1-4632-b1a2-4f61043c018d	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Golden State Medical Supply, Inc.	c2c79af6-f35e-5cdf-e053-2a95a90a4d63	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Amici Pharma Inc.	f2908870-a517-491f-8771-4100d11b4b64	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Lifsa Drugs LLC	90a0539a-7227-4b91-8b22-25b6f23ef35f	2025-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Preferred Pharmaceuticals Inc.	8dfaa874-d6cf-4107-b57f-25dab02aa201	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Preferred Pharmaceuticals Inc.	4f482f98-ef10-45d7-8e9f-9cf291d93092	2025-03-14	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