FDA.reportPublic FDA data

Application 021222

Type
NDA
Sponsor
VANSEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPECTRACEFCEFDITOREN PIVOXILTABLET;ORAL200MGNoNo
002SPECTRACEFCEFDITOREN PIVOXILTABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44004-801Spectracefcefditoren pivoxilVansen Pharma Inc.NDACurrent
44004-802SpectracefCefditoren PivoxilVansen Pharma Inc.NDACurrent
44009-801Cefditoren Pivoxilcefditoren pivoxilPharma RomLev Inc.NDACurrent
44009-802Cefditoren Pivoxilcefditoren pivoxilPharma RomLev Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
36373SUPPL2012-08-07
27094SUPPL2012-08-07
14651SUPPL2012-08-07
4660SUPPL2012-08-07
27092SUPPL2009-11-12
4659SUPPL2008-08-05
14650SUPPL2008-07-23
27093SUPPL2006-01-19
36372SUPPL2006-01-06
27091SUPPL2004-03-28
27090SUPPL2002-08-26
14649SUPPL2002-08-21
21516ORIG2001-12-07
14648ORIG2001-08-29
4658ORIG2001-08-29