Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074473
Company: RISING

Products on ANDA 074473

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 600MG BASE	TABLET;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1994	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
08/31/2023	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/25/2008	SUPPL-9	Labeling		Label is not available on this site.
09/22/2006	SUPPL-6	Labeling		Label is not available on this site.
08/02/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/30/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/30/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/01/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.