FDA.reportPublic FDA data

Application 064082

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN TRIHYDRATEAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 250MG BASENoNo
002AMPICILLIN TRIHYDRATEAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 500MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-2144AmpicillinAmpicillinSandoz IncANDACurrent
0781-2144AmpicillinAmpicillinSandoz IncANDACurrent
0781-2144AmpicillinAmpicillinSandoz IncANDACurrent
0781-2144AmpicillinAmpicillinSandoz IncANDACurrent
0781-2145AmpicillinAmpicillinSandoz IncANDACurrent
0781-2145AmpicillinAmpicillinSandoz IncANDACurrent
0781-2145AmpicillinAmpicillinSandoz IncANDACurrent
0781-2145AmpicillinAmpicillinSandoz IncANDACurrent
68071-1981AmpicillinAmpicillinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1981AmpicillinAmpicillinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1981AmpicillinAmpicillinNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7139AmpicillinAmpicillinPreferred Pharmaceuticals Inc.ANDACurrent
70518-1014AmpicillinAmpicillinREMEDYREPACK INC.ANDACurrent
70518-1014AmpicillinAmpicillinREMEDYREPACK INC.ANDACurrent
70518-2607AmpicillinAmpicillinREMEDYREPACK INC.ANDACurrent
70518-2607AmpicillinAmpicillinREMEDYREPACK INC.ANDACurrent
70518-2607AmpicillinAmpicillinREMEDYREPACK INC.ANDACurrent
70934-059AmpicillinAmpicillinDenton Pharma, Inc.ANDACurrent
70934-059AmpicillinAmpicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-059AmpicillinAmpicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-417AmpicillinAmpicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-417AmpicillinAmpicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-417AmpicillinAmpicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent