FDA.reportPublic FDA data

Application 021945

Type
NDA
Sponsor
AMAG PHARMA USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAKENAHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR1250MG/5ML (250MG/ML)YesYes
002MAKENA PRESERVATIVE FREEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR250MG/ML (250MG/ML)YesYes
003MAKENA PRESERVATIVE FREEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR250MG/ML (250MG/ML)YesNo
004MAKENA (AUTOINJECTOR)HYDROXYPROGESTERONE CAPROATESOLUTION;SUBCUTANEOUS275MG/1.1ML (250MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64011-243Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-243Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-243Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-247Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-247Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-247Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-301Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-301Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
64011-301Makenahydroxyprogesterone caproateAMAG Pharmaceuticals, Inc.NDACurrent
66993-038Hydroxyprogesterone Caproatehydroxyprogesterone caproatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-038Hydroxyprogesterone Caproatehydroxyprogesterone caproatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-039Hydroxyprogesterone Caproatehydroxyprogesterone caproatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-039Hydroxyprogesterone Caproatehydroxyprogesterone caproatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58983SUPPL2019-06-06
55073SUPPL2018-08-02
52649SUPPL2018-02-15
52648SUPPL2018-02-15
49490SUPPL2017-08-21
49440SUPPL2017-08-17
6514SUPPL2013-09-17
16618SUPPL2013-09-16
44660ORIG2012-10-31
21881ORIG2012-10-31
6513ORIG2011-02-10
37933ORIG2011-02-03
53292ORIG1900-01-01
53291ORIG1900-01-01
53290ORIG1900-01-01