FDA.reportPublic FDA data

Application 022474

Type
NDA
Sponsor
LAB HRA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELLAULIPRISTAL ACETATETABLET;ORAL30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2835Ellaulipristal acetateA-S Medication SolutionsNDACurrent
50090-2835Ellaulipristal acetateA-S Medication SolutionsNDACurrent
50090-5422Ellaulipristal acetateA-S Medication SolutionsNDACurrent
50102-911Ellaulipristal acetateAfaxys Pharma LLCNDACurrent
50102-911Ellaulipristal acetateAfaxys Pharma LLCNDACurrent
53002-1630Ellaulipristal acetateRPK Pharmaceuticals, Inc.NDACurrent
53002-1630Ellaulipristal acetateRPK Pharmaceuticals, Inc.NDACurrent
53002-2630Ellaulipristal acetateRPK Pharmaceuticals, Inc.NDACurrent
73302-456Ellaulipristal acetateHRA Pharma America, Inc.NDACurrent
73302-456Ellaulipristal acetateHRA Pharma America, Inc.NDACurrent
82454-0456Ellaulipristal acetateCENEXI HSCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67919SUPPL2021-06-28
67901SUPPL2021-06-25
54013SUPPL2018-05-04
54000SUPPL2018-05-03
22032SUPPL2015-03-31
17633SUPPL2015-03-12
7450SUPPL2015-03-11
29768SUPPL2014-09-03
38755SUPPL2014-08-28
17632SUPPL2014-06-17
7449SUPPL2014-06-17
38754SUPPL2012-05-07
7448SUPPL2012-05-04
24318ORIG2010-09-17
22031ORIG2010-09-17
38753ORIG2010-08-13
7447ORIG2010-08-13
54135ORIG1900-01-01
54134ORIG1900-01-01
54133ORIG1900-01-01
54132ORIG1900-01-01