FDA.reportPublic FDA data

Application 018662

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ACCUTANEISOTRETINOINCAPSULE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ACCUTANEISOTRETINOINCAPSULE;ORAL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004ACCUTANEISOTRETINOINCAPSULE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44440ORIG2015-07-02
1016SUPPL2010-10-26
23122SUPPL2010-10-25
1015SUPPL2010-02-05
33551SUPPL2010-02-04
33550SUPPL2009-06-10
15084SUPPL2008-11-21
33549SUPPL2007-10-10
1014SUPPL2007-10-10
40823SUPPL2007-07-06
40822SUPPL2007-07-06
40821SUPPL2007-07-06
40820SUPPL2007-07-06
40819SUPPL2007-07-06
40818SUPPL2007-07-06
40817SUPPL2007-07-06
20146SUPPL2007-07-06
20145SUPPL2007-07-06
15083SUPPL2005-08-15
11271SUPPL2005-08-12
44025ORIG2005-07-28
15082SUPPL2004-08-25
11270SUPPL2004-08-25
1013SUPPL2004-05-25
33548SUPPL2003-08-29
11269SUPPL2003-08-29
1011SUPPL2003-08-27
11268SUPPL2002-06-20
1012SUPPL2002-06-20
33544SUPPL2002-05-02
1009SUPPL2002-05-02
43560SUPPL2002-04-12
15081SUPPL2002-04-12
33547SUPPL2002-02-15
15080SUPPL2002-02-15
33546SUPPL2001-12-31
15079SUPPL2001-12-31
11267SUPPL2001-12-31
1008SUPPL2001-12-31
33545SUPPL2001-10-30
1010SUPPL2001-10-30
15078SUPPL2000-05-01
1007SUPPL2000-05-01
1006SUPPL2000-05-01