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FDA Drug Application 012827 by CASPER PHARMA LLC

Application Number012827
Application Type New Drug Application
Sponsor ApplicantCASPER PHARMA LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/11/1961N       
AP012/17/1975SOA       
AP02/18/1976SCS23287009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul & Robinul Forte_Tablets.pdf 9/14/2009
AP02/18/1976SCE23288010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul%20&%20Robinul%20Forte_Tablets.pdf 9/14/2009
AP02/18/1976SCE23289011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul%20&%20Robinul%20Forte_Tablets.pdf 9/14/2009
AP07/9/1976SCP       
AP012/29/1976SCS       
AP07/13/1977SCS23292014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s014_Robinul_Forte_Tabs.pdf 9/14/2009
AP09/27/1977SCS23293015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s015_Robinul - Robinul_Forte_Tabs.pdf 9/14/2009
AP08/23/1978SCE       
AP02/22/1979SCS23294017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s017_Robinul-Robinul_Forte_Tabs.pdf 9/14/2009
AP04/6/1979SLR       
AP04/12/1979SLR       
AP07/24/1979SLR       
AP01/7/1980SCS       
AP01/7/1980SLR       
AP06/26/1980SCP       
AP01/30/1981SCP23295024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s024&s025_Robinul_Robinul_Forte_Tabs.pdf 9/14/2009
AP01/30/1981SCS23296025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s024&s025_Robinul_Robinul_Forte_Tabs.pdf 9/14/2009
AP02/5/1981SCM       
AP011/6/1981SCP       
AP02/18/1982SCP       
AP011/3/1982SCP       
AP01/4/1983SCM       
AP011/7/1983SCF23297032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s032&s033_Robinul & Robinul Forte Tablets.pdf 9/14/2009
AP011/7/1983SCF23298033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s032&s033_Robinul & Robinul Forte Tablets.pdf 9/14/2009
AP07/16/1985SLR       
AP04/22/1986SCS23299035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s035_Robinul Forte Tablets.pdf 9/14/2009
AP09/16/1986SCS       
AP03/15/1988SCS       
AP08/19/1988SCM       
AP010/27/1988SCM       
AP02/13/1990SCM       
AP01/23/1998SCM       
AP012/7/1999SCM       
AP01/15/2002SCM       
AP01/15/2002SCP       
AP06/21/2002SCM       
AP010/18/2002SCM       
AP07/25/2003SCP6413049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12827scp049ltr.pdf 8/6/2003
AP07/31/2015SCM       




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