Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077936
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Discontinued None No No
MELOXICAM MELOXICAM 15MG TABLET;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
07/19/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077936s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

10/17/2016 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/17/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/13/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/02/2010 SUPPL-11 Labeling-Patient Package Insert

Label is not available on this site.

07/07/2010 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/09/2008 SUPPL-7 Labeling

Label is not available on this site.

06/28/2008 SUPPL-6 Labeling

Label is not available on this site.

02/11/2008 SUPPL-4 Labeling

Label is not available on this site.

06/19/2007 SUPPL-3 Labeling

Label is not available on this site.

06/07/2007 SUPPL-2 Labeling

Label is not available on this site.

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