FDA.reportPublic FDA data

Application 090439

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 125MG BASENoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 250MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent
68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDACurrent