FDA.reportPublic FDA data

Application 020624

Type
NDA
Sponsor
US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANZEMETDOLASETRON MESYLATEINJECTABLE;INJECTION100MG/5ML (20MG/ML)YesNo
002ANZEMETDOLASETRON MESYLATEINJECTABLE;INJECTION12.5MG/0.625ML (20MG/ML)YesNo
003ANZEMETDOLASETRON MESYLATEINJECTABLE;INJECTION500MG/25ML (20MG/ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
2900SUPPL2014-09-23
34973SUPPL2014-09-22
34972SUPPL2013-09-17
2899SUPPL2013-09-17
34971SUPPL2011-09-29
25339SUPPL2011-09-27
2898SUPPL2009-11-10
34970SUPPL2009-10-14
41488SUPPL2008-02-19
25338SUPPL2007-09-26
20769SUPPL2007-07-06
12861SUPPL2007-06-04
2897SUPPL2007-06-04
25337SUPPL2005-06-07
12860SUPPL2005-06-07
2896SUPPL2004-05-27
25336SUPPL2003-07-28
25335SUPPL2002-03-22
41487ORIG1998-10-20