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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075986
Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG 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
06/21/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75986lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75986ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075986_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-18 REMS - PROPOSAL - D-N-A

Label is not available on this site.
11/09/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
10/28/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
03/14/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
07/28/2004 SUPPL-3 Labeling

Label is not available on this site.
06/03/2003 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/21/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75986lbl.pdf
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