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FDA Drug Application 020907 by AMNEAL PHARMS LLC

Application Number020907
Application Type New Drug Application
Sponsor ApplicantAMNEAL PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/18/1998N567000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20907ltr.pdf 11/18/1998
AP011/18/1998N568000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20907.cfm 11/18/1998
AP011/18/1998N569000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf 11/18/1998
AP011/3/1999SCM13237001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020907_S001.pdf 12/8/2005
AP02/10/2000SLR13236002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S002.pdf 12/8/2005
AP04/11/2000SLR13235003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S003.pdf 12/8/2005
AP011/14/2000SCM13234004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S004.pdf 12/8/2005
AP06/30/2005SLR11935005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf 7/7/2005
AP06/30/2005SLR11950005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020907s005ltr.pdf 7/8/2005
AP09/13/2002SCM13233006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020907_S006.pdf 12/8/2005
AP07/26/2004S13232007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020907_S007.pdf 12/8/2005
AP012/28/2006SE215595009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf 1/8/2007
AP012/28/2006SE215619009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf 1/8/2007
AP012/28/2006SLR15620011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf 1/8/2007
AP012/28/2006SLR15596011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf 1/8/2007
AP010/8/2013SLR37402013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020907Orig1s013ltr.pdf 10/10/2013
AP010/8/2013SLR37448013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf 10/17/2013
AP01/12/2015SCM       
AP05/27/2016SCM       




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