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FDA Drug Application 013718 by GEMINI LABS LLC

Application Number013718
Application Type New Drug Application
Sponsor ApplicantGEMINI LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/21/1964N       
AP011/30/1979SCM       
AP02/24/1987SLR       
AP010/23/1991SLR       
AP07/31/1997SCP       
AP010/1/1999SCS       
AP08/23/1999SCS       
AP011/5/2001SCS3089020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf 11/5/2001
AP011/5/2001SCS5897020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf 6/10/2003
AP011/5/2001SCF3090021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf 11/5/2001
AP011/5/2001SCF5898021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf 6/10/2003
AP04/21/2003SLR5654022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13718slr022_Oxandrin_lbl.pdf 5/28/2003
AP04/21/2003SLR5717022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13718slr022ltr.pdf 5/29/2003
AP04/21/2003SLR15217022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/013718_S022_Oxandrin Tabs_APPROVAL PACKAGE.pdf 10/25/2006
AP06/20/2005SE811848023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013718s023ltr.pdf 6/21/2005
AP06/20/2005SE811849023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf 6/21/2005




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