FDA.reportPublic FDA data

Application 021749

Type
NDA
Sponsor
HAMELN PHARMA PLUS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70651-001Pentetate calcium trisodiumpentetate calcium trisodiumhameln pharma gmbhNDACurrent
70651-001Pentetate calcium trisodiumpentetate calcium trisodiumhameln pharma plus gmbhNDACurrent
70651-001Pentetate calcium trisodiumpentetate calcium trisodiumhameln pharma plus gmbhNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
16303SUPPL2013-03-26
6113SUPPL2013-03-22
6112SUPPL2005-08-08
42297ORIG2004-10-20
44149ORIG2004-08-11
37578ORIG2004-08-11
28516ORIG2004-08-11
24008ORIG2004-08-11