Application 074399

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLMETIN SODIUM	TOLMETIN SODIUM	TABLET;ORAL	EQ 600MG BASE	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
A074399-001	TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL			1996-03-28

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	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074399-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	1996-03-28	`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 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 brand name: Tolmetin Sodium 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 brand name: Tolmetin Sodium 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 brand name: TOLMETIN SODIUM 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 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 brand name: Tolmetin Sodium 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 brand name: Tolmetin Sodium generic name: TOLMETIN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.