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FDA Drug Application 020385 by PFIZER INC

Application Number020385
Application Type New Drug Application
Sponsor ApplicantPFIZER INC
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
AP03/22/1996N       
AP08/14/1998SCM       
AP07/9/2001SLR       
AP09/8/2002SLR2966005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20385slr005ltr.pdf 9/8/2002
AP011/6/2003SLR6975006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20385slr006,20714slr011ltr.pdf 11/25/2003
AP07/16/2004SLR9778007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20385s007,20714s012ltr.pdf 7/21/2004
AP06/29/2010SLR25881010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020385s010ltr.pdf 7/1/2010
AP06/29/2010SLR25895010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020385s010lbl.pdf 7/1/2010




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