Application 017651

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/MLNoNo
005HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/MLNoNo
006HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/MLYesYes
008HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION20,000 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-047Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCNDACurrent
63323-047Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCNDACurrent
63323-047Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80008SUPPL 2024-10-28
79994SUPPL 2024-10-25
67736SUPPL2021-06-08
63805SUPPL2020-07-06
63796SUPPL2020-07-06
677SUPPL2014-04-07
676SUPPL2011-12-29
33328SUPPL2011-12-23
675SUPPL2011-07-05
11051SUPPL2010-06-24
13878SUPPL2010-06-14
33327SUPPL2009-04-03
674SUPPL2009-04-03
13877SUPPL2008-01-09
20081ORIG2007-07-20