FDA.reportPublic FDA data

Application 212721

Type
ANDA
Sponsor
ASTRAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70594-089CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-089CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-089CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-090CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-090CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-090CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
71288-020Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-021Cefepimecefepime hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent