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FDA Drug Application 075189 by IMPAX LABS INC

Application Number075189
Application Type Abbreviated New Drug Application
Sponsor ApplicantIMPAX LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/26/2000N557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75189AP-TA.PDF 5/26/2000
TA112/24/1998TA557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75189AP-TA.PDF 5/26/2000
AP05/26/2000N2886000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone.cfm 5/26/2000
TA112/24/1998TA2886000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone.cfm 5/26/2000
AP05/26/2000N4823000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf 5/26/2000
TA112/24/1998TA4823000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf 5/26/2000
AP05/26/2000N9241000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75189ta.pdf 6/9/2004
TA112/24/1998TA9241000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75189ta.pdf 6/9/2004
AP09/24/2001SCS5111001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf 4/9/2003
AP09/24/2001SL5112002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf 4/9/2003
AP06/21/2002SCR       
AP05/21/2002SL       




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