FDA.reportPublic FDA data

Application 022159

Type
NDA
Sponsor
SEPTODONT HOLDING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORAVERSEPHENTOLAMINE MESYLATEINJECTABLE;INJECTION0.4MG/1.7MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-0101OraversePhentolamine MesylateSeptodont, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29338SUPPL2016-03-23
17034SUPPL2016-03-22
21949ORIG2009-08-26
44688ORIG2008-07-17
6985ORIG2008-05-14
66983SUPPL1900-01-01
63540ORIG1900-01-01
51463ORIG1900-01-01
51462ORIG1900-01-01