Application 073393

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLMETIN SODIUM	TOLMETIN SODIUM	CAPSULE;ORAL	EQ 400MG BASE	No	No

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

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
A073393-001	TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		1993-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		1993-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		1993-05-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	RS	1993-05-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A073393-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073393-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073393-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073393-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073393-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073393-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073393-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073393-001	AB	1	`ea99ee380514…`

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
TOLMETIN SODIUM	TOLMETIN SODIUM	Galt Pharmaceuticals, LLC	0a97800f-706d-4787-98fe-08dadf9c4d5f	2026-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073393 application number: ANDA073393
Tolmetin Sodium	TOLMETIN SODIUM	Atland Pharmaceuticals, LLC	41b7704e-25a1-45e8-93c0-9ac2f0effef9	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073393 application number: ANDA073393

Reported adverse events (FAERS/openFDA)#

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

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
0378-5200	Tolmetin Sodium	tolmetin Sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5200	Tolmetin Sodium	tolmetin Sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5200	Tolmetin Sodium	tolmetin Sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5200	Tolmetin Sodium	tolmetin Sodium	Mylan Pharmaceuticals Inc.	ANDA	Current