FDA.reportPublic FDA data

Application 020212

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZINECARDDEXRAZOXANE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 250MG BASE/VIALYesYes
002ZINECARDDEXRAZOXANE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0013-8717ZinecarddexrazoxanePharmacia and Upjohn Company LLCNDACurrent
0013-8717ZinecarddexrazoxanePharmacia and Upjohn Company LLCNDACurrent
0013-8727ZinecarddexrazoxanePharmacia and Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82176SUPPL 2025-05-14
82252SUPPL 2025-05-12
57642ORIG2019-02-15
12320SUPPL2014-04-29
24581SUPPL2014-04-21
34373SUPPL2012-07-13
24580SUPPL2012-07-09
34372SUPPL2005-05-25
2169SUPPL2005-05-25
34371SUPPL2002-10-31
34370SUPPL2002-10-31
24579SUPPL2002-10-31
24578SUPPL2002-10-31
12319SUPPL2002-10-31
2168SUPPL2002-10-31