Application 077394

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM BICARBONATESODIUM BICARBONATEINJECTABLE;INJECTION0.9MEQ/MLNoYes
002SODIUM BICARBONATESODIUM BICARBONATEINJECTABLE;INJECTION1MEQ/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52584-637Sodium BicarbonateSodium BicarbonateGeneral Injectables & Vaccines, IncANDACurrent
52584-637Sodium BicarbonateSodium BicarbonateGeneral Injectables & Vaccines, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39529ORIG2012-11-26
31234ORIG2005-11-18