FDA.reportPublic FDA data

Application 210723

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR250MG/ML (250MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-1767Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmerican Regent, Inc.ANDACurrent
0517-1767Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmerican Regent, Inc.ANDACurrent
0517-1767Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmerican Regent, Inc.ANDACurrent
0517-1791Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmerican Regent, Inc.ANDACurrent
0517-1791Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmerican Regent, Inc.ANDACurrent
0517-1791Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmerican Regent, Inc.ANDACurrent
69238-1797Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmneal Pharmaceuticals of NY LLCANDACurrent
69238-1797Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmneal Pharmaceuticals of NY LLCANDACurrent
69238-1797Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1797Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAmneal Pharmaceuticals of NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54815ORIG2018-07-06