Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076168
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 80MG TABLET, EXTENDED RELEASE; ORAL None (Tentative Approval) 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
09/29/2003 ORIG-1 Tentative Approval Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168pilbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076168_s000_OxycodoneTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2004 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2003 ORIG-1 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf

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