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FDA Drug Application 011522 by TEVA WOMENS

Application Number011522
Application Type New Drug Application
Sponsor ApplicantTEVA WOMENS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/19/1960N16662000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111441.htm 5/31/2007
AP02/13/1996SLR       
AP02/13/1996SCF3711010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/11522S010_Adderall.pdf 6/12/2000
AP07/17/1997SLR       
AP01/29/1997SCS       
AP05/12/1997SCM       
AP06/13/1997SCS       
AP07/17/1997SLR       
AP011/14/1997SCS       
AP07/25/1997SLR       
AP01/8/1998SCS       
AP03/16/1998SCS       
AP02/23/1999SCM       
AP05/21/1999SCM       
AP011/12/1999SCS       
AP09/20/1999SCS       
AP01/26/2000SCM       
AP02/15/2000SCM       
AP08/31/2000SCM       
AP07/24/2000SCS       
AP012/10/2001SCS       
AP04/11/2002SCM       
AP011/8/2002SCF2630030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11522scf030ltr.pdf 11/8/2002
AP011/8/2002SCF8336030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/11-522S030_Adderall.cfm 4/14/2004
AP08/2/2005SLR12536032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf 8/4/2005
AP08/2/2005SLR12539032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf 8/4/2005
AP08/2/2005SLR12537033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf 8/4/2005
AP08/2/2005SLR12538033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011522s032,033ltr.pdf 8/4/2005
AP07/26/2006SLR14539034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf 7/27/2006
AP07/26/2006SLR14551034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf 7/27/2006
AP07/26/2006SLR14552037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf 7/27/2006
AP07/26/2006SLR14540037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf 7/27/2006
AP06/7/2007SLR16752040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf 6/12/2007
AP06/7/2007SLR16774040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011522s040ltr.pdf 6/14/2007
AP04/17/2015SLR42567041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf 4/19/2015
AP04/17/2015SLR42585041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s041ltr.pdf 4/20/2015
AP010/1/2015SLR44112042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011522Orig1s042ltr.pdf 10/6/2015
AP010/1/2015SLR44166042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf 10/7/2015
AP010/1/2015SLR44275042   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf 10/23/2015




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