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 1 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, FILM COATED	Amerisyn LLC	b0931350-28a9-4f00-9254-1d72e31f04c3	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Par Health USA, LLC	2d45648f-cbea-41a4-8e3e-007b7bb7912c	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Sun Pharmaceutical Industries, Inc.	68a926a2-b818-420f-9c9a-fd91dc5a8f36	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
diclofenac potassium	DICLOFENAC POTASSIUM	Strides Pharma Science Limited	2184805c-b9b3-4be8-8726-4ce1b1197477	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	REMEDYREPACK INC.	c4976d69-ca06-4263-9240-6fd8b44a9b6d	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals,Inc.	d61cbb27-737d-948c-e053-2a95a90adaca	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM, FILM COATED	VICI Pharmaceuticals, Inc	544a869e-60ef-627b-e063-6294a90a3fd8	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	86461915-9bc1-43d4-8d92-6eef3e56bd90	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	e29e7aea-0bcd-46e5-b011-fbaf5aa2244a	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	Umedica Laboratories USA Inc.	1fa07fbe-3708-4200-b3ff-a920434896b6	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium
Diclofenac Potassium	DICLOFENAC POTASSIUM 25 MG	PureTek Corporation	4a828eb5-0383-f524-e063-6394a90a8449	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	Bryant Ranch Prepack	94898228-c595-4fd6-acc2-13dbdbde9c0e	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	Torrent Pharmaceuticals Limited	6a945fa8-6c62-40ba-ae97-b994cc90583e	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM generic name: DICLOFENAC POTASSIUM
ZIPSOR	DICLOFENAC POTASSIUM	Assertio Specialty Pharmaceuticals LLC	ed2a8868-78eb-47b8-8f46-0f70e2891e07	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	Umedica Laboratories USA Inc.	33930285-dd97-415c-9e2a-491bd7b12af9	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC POTASSIUM generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	AvKARE	21dc9953-4e6d-50f0-e063-6294a90ac4ef	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	PHOENIX RX LLC	43448b74-6c02-a581-e063-6394a90a63ba	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM TABLETS	Zydus Pharmaceuticals (USA) Inc.	1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium
Diclofenac Potassium	DICLOFENAC POTASSIUM	SOLA Pharmaceuticals, LLC	e770efc8-bbad-4103-98e4-e31019a540f5	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Potassium generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	Northwind Health Company, LLC	f2b6a4dd-e4e2-4acc-e053-2995a90aebf2	2026-01-01	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