Back to FDA Applications sponsored by MIKART

FDA Drug Application 081051 by MIKART

Application Number081051
Application Type Abbreviated New Drug Application
Sponsor ApplicantMIKART
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/28/1992N12022000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051sup.pdf 7/15/2005
AP01/29/1997SL12167001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-001.pdf 7/22/2005
AP03/2/1995SC12210002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051_S-002.pdf 7/22/2005
AP03/6/1996SL12202003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-003.pdf 7/22/2005
AP03/6/1996SL12203004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-004.pdf 7/22/2005
AP07/25/1995SC12211005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051_S-005.pdf 7/22/2005
AP06/8/1995SL12212006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/081051_S-006.pdf 7/22/2005
AP01/18/1996SC12204007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-007.pdf 7/22/2005
AP04/17/2001SL12117008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/081051_S-008.pdf 7/22/2005
AP010/1/1997SC12168009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf 7/22/2005
AP010/1/1997SC12169011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf 7/22/2005
AP010/1/1997SC12170012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf 7/22/2005
AP010/1/1997SL12171013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/081051_S-009;S-011;S-012;S-013.pdf 7/22/2005
AP07/24/1996SL12205014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/081051_S-014.pdf 7/22/2005
AP07/31/1998SC12158015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/081051_S-015.pdf 7/22/2005
AP010/27/1999SCA12155016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/081051_S-016;S-017.pdf 7/22/2005
AP010/27/1999SCE12156017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/081051_S-016;S-017.pdf 7/22/2005
AP08/13/2002SCB12097018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/081051_S-018.pdf 7/22/2005
AP012/12/2002SL12098020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/081051_S-020.pdf 7/22/2005
AP01/13/2004S12046021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/081051_S-021.pdf 7/22/2005




Back to FDA Applications sponsored by MIKART