Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075851
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAPROZIN OXAPROZIN 600MG 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
08/17/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75851ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2003 SUPPL-2 Labeling

Label is not available on this site.

03/13/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf

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