FDA.reportPublic FDA data

Application 216591

Type
ANDA
Sponsor
ASPIRO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-210VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-211VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECamber Pharmaceuticals, Inc.ANDACurrent