FDA.reportPublic FDA data

Application 050606

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 125MG BASEYesNo
002VANCOCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 250MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-310Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-310Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-310Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-310Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-310Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-311Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-311Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-311Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-311Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-311Vancocinvancomycin hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-390vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-390vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-390vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-390vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-390vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-391vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-391vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-391vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-391vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-391vancomycin hydrochloridevancomycin hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69785SUPPL2021-12-27
69761SUPPL2021-12-27
66044SUPPL2021-02-01
66030SUPPL2021-02-01
64268SUPPL2020-08-12
64265SUPPL2020-08-12
7878SUPPL2011-12-15
39035SUPPL2011-12-14
30159SUPPL2010-01-14
39034SUPPL2004-06-01
30158SUPPL2004-06-01
30157SUPPL2004-03-24
7877SUPPL2002-05-24