FDA.reportPublic FDA data

Application 021751

Type
NDA
Sponsor
HAMELN PHARMA PLUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTETATE ZINC TRISODIUMPENTETATE ZINC TRISODIUMSOLUTION;INHALATION, INTRAVENOUSEQ 1GM BASE/5ML (EQ 200MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70651-002Pentetate zinc trisodiumPentetate zinc trisodiumhameln pharma gmbhNDACurrent
70651-002Pentetate zinc trisodiumPentetate zinc trisodiumhameln pharma plus gmbhNDACurrent
70651-002Pentetate zinc trisodiumPentetate zinc trisodiumhameln pharma plus gmbhNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
37579SUPPL2013-03-26
6115SUPPL2013-03-22
28517SUPPL2005-08-08
21803ORIG2004-10-20
16304ORIG2004-08-11
6114ORIG2004-08-11