Application 074473

Type: ANDA
Sponsor: MYLAN

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074473-001	TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		RS	1994-08-30

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL	RS	1994-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074473-001	TOLMETIN SODIUM	EQ 600MG BASE	TABLET / ORAL		1994-08-30	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolectin	TOLMETIN SODIUM	Poly Pharmaceuticals, Inc.	15467b19-e43a-5be9-e063-6294a90a3cca	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074473 application number: ANDA074473
Tolmetin Sodium	TOLMETIN SODIUM	Atland Pharmaceuticals, LLC	e6150446-c5ef-4437-b488-067876649fcc	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074473 application number: ANDA074473

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0313	Tolmetin Sodium	tolmetin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0313	Tolmetin Sodium	tolmetin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0313	Tolmetin Sodium	tolmetin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0313	Tolmetin Sodium	tolmetin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current