Application 018445

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOLOBID	DIFLUNISAL	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	DOLOBID	DIFLUNISAL	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N018445-001	DOLOBID	DIFLUNISAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1982-04-19
N018445-002	DOLOBID	DIFLUNISAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1982-04-19

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UTC	2019-12	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018445-001	DOLOBID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018445-002	DOLOBID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-04-19	`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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
diflunisal	DIFLUNISAL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	666f89b4-fd81-420a-a390-eb1cd4014f61	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIFLUNISAL
Dolobid	DIFLUNISAL	INA Pharmaceutics Inc	725234b2-0e23-45c3-a42d-eb4e62273f9b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dolobid generic name: DIFLUNISAL
Diflunisal	DIFLUNISAL	Zydus Lifesciences Limited	d7a722be-4612-4b2e-827d-56fb5eef0aae	2024-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIFLUNISAL
Diflunisal	DIFLUNISAL	Chartwell RX, LLC	2043bab8-87c9-45ce-88c7-383f0d4c4b64	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIFLUNISAL
Diflunisal	DIFLUNISAL	Zydus Pharmaceuticals (USA) Inc.	5baf9f35-6b5e-4666-a14a-ac0f9d4e9f76	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIFLUNISAL
Diflunisal	DIFLUNISAL	Teva Pharmaceuticals USA, Inc.	7a78bb38-14d8-4a90-b883-482d4cebf716	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIFLUNISAL

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
11219	SUPPL	2007-03-23
922	SUPPL	2007-03-23
15003	SUPPL	2006-01-30
33491	SUPPL	2006-01-25