Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073290
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLMETIN SODIUM TOLMETIN SODIUM EQ 400MG BASE CAPSULE;ORAL Prescription AB No Yes
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
05/09/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

01/11/2007 SUPPL-13 Labeling

Label is not available on this site.

03/08/2006 SUPPL-12 Labeling

Label is not available on this site.

03/17/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/18/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/22/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/31/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TOLMETIN SODIUM

CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOLMETIN SODIUM TOLMETIN SODIUM EQ 400MG BASE CAPSULE;ORAL Prescription No AB 073393 MYLAN
TOLMETIN SODIUM TOLMETIN SODIUM EQ 400MG BASE CAPSULE;ORAL Prescription No AB 073290 TEVA

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