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FDA Drug Application 020262 by HQ SPCLT PHARMA

Application Number020262
Application Type New Drug Application
Sponsor ApplicantHQ SPCLT PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1992N       
AP06/25/1993SCM       
AP07/23/1993SLR       
AP06/22/1994SE2       
AP04/13/1994SE1       
AP03/16/1994SCM       
AP04/21/1994SCS       
AP010/19/1994SCM       
AP07/22/1994SCM       
AP02/15/1995SCS       
AP05/5/1995SCF       
AP04/1/1996SLR       
AP04/3/1996SCS       
AP01/8/1999SLR182014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf 1/8/1999
AP012/13/1996SCP       
AP01/8/1999SLR195016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf 1/8/1999
AP03/5/1997SCM       
AP09/18/1997SCM       
AP04/25/1997SCM       
AP01/8/1999SLR300021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf 1/8/1999
AP08/4/1997SE1       
AP04/1/1998SCS       
AP06/30/1998SE1471024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262s24ltr.pdf 6/30/1998
AP06/30/1998SE1472024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20262s024.cfm 9/9/1999
AP06/30/1998SE1473024   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262s24lbl.pdf 6/30/1998
AP012/19/1997SCS       
AP04/9/1998SE1632026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf 4/9/1998
AP04/9/1998SE1633026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm 6/15/2000
AP04/9/1998SE1634026   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 4/9/1998
AP04/9/1998SLR3915027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf 4/9/1998
AP04/9/1998SLR3918027   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 4/9/1998
AP04/9/1998SLR3919027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm 6/15/2000
AP04/9/1998SLR3920028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020262s026s027s028.cfm 6/15/2000
AP04/9/1998SLR3916028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20262sltr.pdf 4/9/1998
AP04/9/1998SLR3917028   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 4/9/1998
AP011/5/1998SCM       
AP03/19/1999SCS       
AP01/8/1999SLR1167031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20262S031_Taxol.pdf 7/6/2000
AP012/10/1999SLR       
AP010/25/1999SE11289033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20262S33LTR.PDF 10/25/1999
AP010/25/1999SE11290033   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF 10/25/1999
AP08/29/2002SLR3359035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262slr035ltr.pdf 8/29/2002
AP06/20/2000SE21486036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20262S36LTR.PDF 6/20/2000
AP06/20/2000SE21487036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20262S36LBL.PDF 6/20/2000
AP06/20/2000SE213281036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020262s036,037,038_Taxol.pdf 12/16/2005
AP03/4/2002SLR13282037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_Taxol.pdf 12/16/2005
AP03/4/2002SLR3914037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf 3/4/2002
AP03/4/2002SLR3357038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20262s36s37s38ltr.pdf 3/4/2002
AP03/4/2002SLR13283038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020262s036,037,038_Taxol.pdf 12/16/2005
AP04/10/2001SCM       
AP05/23/2001SCS       
AP03/5/2003SLR4504041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20262slr041ltr.pdf 3/26/2003
AP012/12/2002SCP       
AP08/13/2010SLR26297048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf 8/28/2010
AP08/13/2010SLR26364048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020262s048ltr.pdf 9/7/2010
AP05/2/2011SLR28687049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf 5/2/2011
AP05/2/2011SLR28692049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020262s049ltr.pdf 5/4/2011
AP06/27/2014SCM       
AP03/3/2015SLR42013051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020262Orig1s051ltr.pdf 3/4/2015
AP03/3/2015SLR42033051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf 3/5/2015




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