Application 065490

Type
ANDA
Sponsor
STRIDES PHARMA

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
47781-729vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-729vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-729vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-729vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-729vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-730vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-730vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-730vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-730vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-730vancomycin hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8402ORIG2012-04-11