FDA.reportPublic FDA data

Application 065478

Type
ANDA
Sponsor
AKORN

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
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkornANDACurrent
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkornANDACurrent
17478-741Vancomycin HydrochlorideVancomycin HydrochlorideAkornANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkornANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkorn, Inc.ANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkornANDACurrent
17478-742Vancomycin HydrochlorideVancomycin HydrochlorideAkornANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30666ORIG2012-04-11