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FDA Drug Application 021998 by TEVA BRANDED PHARM

Application Number021998
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/10/2009N22939000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf 7/13/2009
AP07/10/2009N22944000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf 7/13/2009
AP07/10/2009N24122000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998_planb_onestep_toc.cfm 11/24/2009
AP07/10/2009N24123000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998s000_SumR.pdf 11/24/2009
AP04/30/2013SE535935002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s002ltr.pdf 5/2/2013
AP04/30/2013SE537220002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s002lbl.pdf 9/24/2013
AP04/30/2013SE544492002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021998Orig1s002.pdf 11/17/2015
AP06/20/2013SE836361003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s003lbl.pdf 6/21/2013
AP06/20/2013SE836366003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s003ltr.pdf 6/24/2013




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