Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073392
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-3 Labeling-Package Insert

Label is not available on this site.

07/29/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

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