FDA.reportPublic FDA data

Application 062882

Type
ANDA
Sponsor
DAVA PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-122AmpicillinAmpicillinBlenheim Pharmacal, Inc.ANDACurrent
52959-389AmpicillinAmpicillinH.J. Harkins Company, Inc.ANDACurrent
63629-2609AmpicillinAmpicillinBryant Ranch PrepackANDACurrent
63629-2610AmpicillinAmpicillinBryant Ranch PrepackANDACurrent
63629-2610AmpicillinAmpicillinBryant Ranch PrepackANDACurrent
66267-025AmpicillinAmpicillinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-025AmpicillinAmpicillinNuCare Pharmaceuticals, Inc.ANDACurrent
67253-180AmpicillinAmpicillinPar PharmaceuticalANDACurrent
67253-180AmpicillinAmpicillinPar PharmaceuticalANDACurrent
67253-181AmpicillinAmpicillinPar PharmaceuticalANDACurrent
67253-181AmpicillinAmpicillinPar PharmaceuticalANDACurrent