Application 017628

Type: NDA
Sponsor: ORTHO MCNEIL JANSSEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLECTIN	TOLMETIN SODIUM	TABLET;ORAL	EQ 200MG BASE	Yes	No
002	TOLECTIN 600	TOLMETIN SODIUM	TABLET;ORAL	EQ 600MG BASE	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
N017628-001	TOLECTIN	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL		RLD, Approved before 1982
N017628-002	TOLECTIN 600	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		RLD	1989-03-08

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	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL		1989-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL		1989-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL		1989-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017628-001	TOLECTIN	EQ 200MG BASE	TABLET / ORAL	RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017628-002	TOLECTIN 600	EQ 600MG BASE	TABLET / ORAL	RLD	1989-03-08	`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
Tolmetin Sodium	TOLMETIN SODIUM	Chartwell RX, LLC	66fa5e73-477c-4bbc-b7d3-f4a69aad4460	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLMETIN SODIUM
Tolmetin Sodium	TOLMETIN SODIUM	Lifsa Drugs LLC	7b26321c-4797-4664-a162-e29de4b8dd93	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLMETIN SODIUM
TOLMETIN SODIUM	TOLMETIN SODIUM	Galt Pharmaceuticals, LLC	0a97800f-706d-4787-98fe-08dadf9c4d5f	2026-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLMETIN SODIUM
Tolectin	TOLMETIN SODIUM	Poly Pharmaceuticals, Inc.	15467b19-e43a-5be9-e063-6294a90a3cca	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tolectin generic name: TOLMETIN SODIUM
Tolmetin Sodium	TOLMETIN SODIUM	Atland Pharmaceuticals, LLC	e6150446-c5ef-4437-b488-067876649fcc	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLMETIN SODIUM
Tolmetin Sodium	TOLMETIN SODIUM	Atland Pharmaceuticals, LLC	41b7704e-25a1-45e8-93c0-9ac2f0effef9	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLMETIN SODIUM

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
43597	ORIG	2009-12-04
33320	SUPPL	2008-01-24
667	SUPPL	2008-01-24
13870	SUPPL	2006-02-22
11050	SUPPL	2006-02-22