FDA.reportPublic FDA data

Application 062373

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 0.8MG BASE/MLNoNo
002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 80MG BASE/100MLNoNo
003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 40MG BASE/100MLNoNo
004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 60MG BASE/100MLNoNo
005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 100MG BASE/100MLNoNo
006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 120MG BASE/100MLNoYes
007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 1.2MG BASE/MLNoNo
008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 1.6MG BASE/MLNoNo
009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoYes
010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 2.4MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0503Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0503Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0503Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0503Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0505Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0505Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0505Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0505Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0507Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0507Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0507Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0507Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0509Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0509Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0509Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0509Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0511Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0511Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0511Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent
0338-0511Gentamicin Sulfate in Sodium ChlorideGentamicin SulfateBaxter Healthcare CorporationANDACurrent