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FDA Drug Application 020438 by ROCHE

Application Number020438
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/22/1995N       
AP02/14/2000SLR2384001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/020438-S001_VESANOID_ltr.pdf 2/14/2000
AP02/14/2000SLR2385001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020438-S001_VESANOID_lbl.pdf 2/14/2000
AP02/14/2000SLR8345001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20438-S001_VESANOID_review.pdf 4/14/2004
AP010/5/2004S10383004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20438s004ltr.pdf 10/8/2004
AP010/5/2004S10404004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20438s004lbl.pdf 10/8/2004
AP07/1/2008SLR20158006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020438s006ltr.pdf 7/8/2008
AP07/1/2008SLR43853006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020438s006lbl.pdf 9/14/2015




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