FDA.reportPublic FDA data

Application 200837

Type
ANDA
Sponsor
SAGENT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5GM BASE/VIALNoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-157Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-157Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-157Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-157Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-158Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-158Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-158Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-158Vancomycinvancomycin hydrochlorideSagent PharmaceuticalsANDACurrent