FDA.reportPublic FDA data

Application 208424

Type
NDA
Sponsor
POHL BOSKAMP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GONITRONITROGLYCERINPOWDER;SUBLINGUAL0.4MG/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
28595-705GONITROnitroglycerinAllegis Pharmaceuticals, Inc.NDACurrent
28595-705GONITROnitroglycerinAllegis Pharmaceuticals, Inc.NDACurrent
70007-400GONITROnitroglycerinEspero Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46030ORIG2016-12-06
19994ORIG2016-06-13
32909ORIG2016-06-10