FDA.reportPublic FDA data

Application 021574

Type
NDA
Sponsor
ANDRX LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORTAMETMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002FORTAMETMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2719Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2720Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
59630-574FORTAMETmetformin hydrochlorideShionogi Inc.NDACurrent
59630-574FORTAMETmetformin hydrochlorideShionogi Inc.NDACurrent
59630-574FORTAMETmetformin hydrochlorideShionogi Inc.NDACurrent
59630-575FORTAMETmetformin hydrochlorideShionogi Inc.NDACurrent
59630-575FORTAMETmetformin hydrochlorideShionogi Inc.NDACurrent
59630-575FORTAMETmetformin hydrochlorideShionogi Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56453SUPPL2018-11-15
56410SUPPL2018-11-12
47951SUPPL2017-04-12
47928SUPPL2017-04-11
37266SUPPL2008-08-13
5770SUPPL2008-07-31
28159SUPPL2007-04-25
15808SUPPL2007-04-20
5769SUPPL2006-02-22
42215ORIG2006-02-08
15807ORIG2004-05-04
28158ORIG2004-04-29