Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071081
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MECLOFENAMATE SODIUM MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE;ORAL Prescription None No Yes
MECLOFENAMATE SODIUM MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE;ORAL Prescription 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
09/03/1986 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
04/28/2021 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/04/2015 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/09/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2002 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/05/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/05/1994 SUPPL-10 Labeling

Label is not available on this site.

01/28/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/05/1992 SUPPL-7 Labeling

Label is not available on this site.

01/31/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/04/1989 SUPPL-5 Labeling

Label is not available on this site.

02/08/1989 SUPPL-4 Labeling

Label is not available on this site.

04/09/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/05/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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