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FDA Drug Application 021113 by WEST-WARD PHARMS INT

Application Number021113
Application Type New Drug Application
Sponsor ApplicantWEST-WARD PHARMS INT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/4/2002N3109000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21113ltr.pdf 3/4/2002
AP03/4/2002N3110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.htm 3/4/2002
AP03/4/2002N3111000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.cfm 3/4/2002
AP03/4/2002N18703000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP09/29/2004SCM10350002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21113s002ltr.pdf 10/4/2004
AP011/14/2005SLR13110004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021113s004ltr.pdf 11/18/2005
AP011/14/2005SLR13118004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021113s004lbl.pdf 11/18/2005
AP010/17/2008SLR21038006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021113s006ltr.pdf 10/21/2008
AP07/27/2009S23174008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf 8/13/2009
AP07/27/2009S24144008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021113s008ltr.pdf 11/25/2009
AP010/17/2012SLR34131012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021113Orig1s012ltr.pdf 10/22/2012
AP010/17/2012SLR34161012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf 10/22/2012
AP012/4/2014SLR41162017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021113Orig1s017ltr.pdf 12/5/2014
AP012/4/2014SLR41200017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf 12/10/2014




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