Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073311
Company: SUN PHARM INDUSTRIES

Products on ANDA 073311

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073311

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/1991	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/30/2021	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/03/2008	SUPPL-16	Labeling		Label is not available on this site.
05/16/2006	SUPPL-15	Labeling		Label is not available on this site.
05/16/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
12/05/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/24/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/12/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.