Application 020142

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CATAFLAM	DICLOFENAC POTASSIUM	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CATAFLAM	DICLOFENAC POTASSIUM	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020142-001	CATAFLAM	DICLOFENAC POTASSIUM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-11-24
N020142-002	CATAFLAM	DICLOFENAC POTASSIUM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-11-24

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1993-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1993-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1993-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1993-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020142-001	CATAFLAM	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020142-002	CATAFLAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-24	`3a93d1ddd44b…`

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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Par Health USA, LLC	2d45648f-cbea-41a4-8e3e-007b7bb7912c	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 generic 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 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 generic 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 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 generic name: DICLOFENAC POTASSIUM
Diclofenac Potassium	DICLOFENAC POTASSIUM	AvKARE	21dc9953-4e6d-50f0-e063-6294a90ac4ef	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback 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 generic 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 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 generic name: DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	Nivagen Pharmaceuticals, Inc.	eb52a015-23cd-40f6-bf83-6749fc34947c	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic 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 generic 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 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 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 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 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
67341	SUPPL	2021-05-03
67340	SUPPL	2021-05-03
67252	SUPPL	2021-04-29
2063	SUPPL	2016-05-12
34296	SUPPL	2016-05-11
12249	SUPPL	2011-03-04
12248	SUPPL	2011-03-04
21204	SUPPL	2011-02-28
21203	SUPPL	2011-02-28
23148	ORIG	2009-11-16
34295	SUPPL	2009-03-17
2062	SUPPL	2009-03-03
21202	SUPPL	2006-01-30
34294	SUPPL	2006-01-25