Application 021626

Type
NDA
Sponsor
HEYL CHEMISCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RADIOGARDASE (PRUSSIAN BLUE)FERRIC HEXACYANOFERRATE(II)CAPSULE;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58060-002RadiogardasePrussian blue insoluble capsulesHeyl Chem.-pharm. Fabrik GmbH & Co. KGNDACurrent
58060-002RadiogardasePrussian blue insoluble capsulesHeyl Chem.-pharm. Fabrik GmbH & Co. KGNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
37349SUPPL2014-08-22
15885SUPPL2008-08-29
28260SUPPL2008-08-27
28259SUPPL2004-05-26
21762ORIG2003-12-31
37348ORIG2003-10-02
5874ORIG2003-10-02