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FDA Drug Application 020441 by ASTRAZENECA

Application Number020441
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/24/1997N       
AP02/11/1998SCM18550001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020441_S001_PULMICORT_TURBUHALER.pdf 11/19/2007
AP010/8/1998SE24196002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20441s2.ltr.pdf 10/8/1998
AP010/8/1998SE24197002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20441s2.lbl.pdf 10/8/1998
AP010/8/1998SE24198002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20441-S002_Pulmicort.cfm 10/8/1998
AP04/12/1999SCM18549003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020441_S003_PULMICORT_TURBUHALER.pdf 11/19/2007
AP05/21/1999SCS18548005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020441_S005_PULMICORT_TURBUHALER.pdf 11/19/2007
AP02/2/2000SCM18547007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020441_S007_PULMICORT_TURBUHALER.pdf 11/19/2007
AP012/9/2000SCS18546009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020441_S009_PULMICORT_TURBUHALER.pdf 11/19/2007
AP010/15/2001SCP18545010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S010_PULMICORT_TURBUHALER.pdf 11/19/2007
AP06/18/2001SCS18544011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S011_PULMICORT_TURBUHALER.pdf 11/19/2007
AP012/31/2001SLR4195012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20441s12ltr.pdf 12/31/2001
AP012/31/2001SLR17212012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S012_Pulmicort Turbuhaler_APPROVAL PACKAGE.pdf 7/9/2007
AP07/3/2001SCS18543013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S013_PULMICORT_TURBUHALER.pdf 11/19/2007
AP05/18/2001SCS18542014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020441_S014_PULMICORT_TURBUHALER.pdf 11/19/2007
AP010/24/2003SLR6866016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr016ltr.pdf 11/5/2003
AP010/24/2003SLR6882016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr016_pulmicort_lbl.pdf 11/5/2003
AP010/24/2003SLR17145016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S016_PULMICORT_TURBUHALER_AP.pdf 7/9/2007
AP012/17/2003SLR7295017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr017ltr.pdf 12/22/2003
AP012/17/2003SLR7443017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr017_pulmicort_lbl.pdf 12/29/2003
AP012/17/2003SLR17053017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S017_PULMICORT_TURBUHALER_AP.pdf 7/6/2007
AP09/26/2003SLR6717018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf 9/30/2003
AP09/26/2003SLR6718018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf 9/30/2003
AP09/26/2003SLR16216018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020441_S018_PULMUICORT_TURBUHALER_AP.pdf 4/11/2007
AP08/20/2007SLR17658020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf 8/21/2007
AP08/20/2007SLR17683020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020441s020ltr.pdf 8/22/2007




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