Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073393
Company: MYLAN
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 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
05/27/1993 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-8 Labeling-Package Insert

Label is not available on this site.

07/31/2008 SUPPL-3 Labeling

Label is not available on this site.

08/08/2006 SUPPL-2 Labeling

Label is not available on this site.

02/05/1998 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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