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FDA Drug Application 076168 by TEVA

Application Number076168
Application Type Abbreviated New Drug Application
Sponsor ApplicantTEVA
Most Recent Label Available Flag
Current Patent Flag
Action Type Tentative Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA09/29/2003TA8071000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf 3/26/2004
AP13/24/2004N8071000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf 3/26/2004
TA21/8/2010TA8071000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76168ltr.pdf 3/26/2004
TA09/29/2003TA8161000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf 3/30/2004
AP13/24/2004N8161000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf 3/30/2004
TA21/8/2010TA8161000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168lbl.pdf 3/30/2004
TA09/29/2003TA8162000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168pilbl.pdf 3/30/2004
AP13/24/2004N8162000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168pilbl.pdf 3/30/2004
TA21/8/2010TA8162000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76168pilbl.pdf 3/30/2004
TA09/29/2003TA13955000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076168_s000_OxycodoneTOC.cfm 4/20/2006
AP13/24/2004N13955000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076168_s000_OxycodoneTOC.cfm 4/20/2006
TA21/8/2010TA13955000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076168_s000_OxycodoneTOC.cfm 4/20/2006




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