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FDA Drug Application 075366 by SANDOZ

Application Number075366
Application Type Abbreviated New Drug Application
Sponsor ApplicantSANDOZ
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
AP05/1/2000N869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf 5/1/2000
AP05/1/2000N3276000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol.cfm 12/18/2001
AP05/1/2000N9432000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf 6/17/2004
AP05/1/2000N9433000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf 6/18/2004
TA17/26/1999TA869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf 5/1/2000
TA17/26/1999TA3276000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol.cfm 12/18/2001
TA17/26/1999TA9432000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf 6/17/2004
TA17/26/1999TA9433000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf 6/18/2004
TA211/2/1999TA869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75366ltr.pdf 5/1/2000
TA211/2/1999TA3276000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol.cfm 12/18/2001
TA211/2/1999TA9432000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-366_Sotalol%20Hydrochloride_prntlbl.pdf 6/17/2004
TA211/2/1999TA9433000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75366ta.pdf 6/18/2004
AP09/7/2000SCB       
AP09/7/2000SCB       
AP010/25/2000SL       
AP04/30/2002SCB       
AP09/18/2002SL       




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