Application 012836

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003PERSANTINEDIPYRIDAMOLETABLET;ORAL25MGYesNo
004PERSANTINEDIPYRIDAMOLETABLET;ORAL50MGYesNo
005PERSANTINEDIPYRIDAMOLETABLET;ORAL75MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0017PersantinedipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0017PersantinedipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0018PersantinedipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0018PersantinedipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0019PersantinedipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0019PersantinedipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
68151-2996DipyridamoleDipyridamoleCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61247SUPPL2019-12-12
61246SUPPL2019-12-12
33096SUPPL2005-08-03
345SUPPL2005-08-03
12038SUPPL2004-08-06