Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073308
Company: ANI PHARMS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/1992 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
05/09/2016 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/27/2016 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/23/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2000 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/03/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/18/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/17/1995 SUPPL-2 Labeling

Label is not available on this site.

02/26/1992 SUPPL-1 Labeling

Label is not available on this site.

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