FDA.reportPublic FDA data

Application 214154

Type
NDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXTSTELLISDROSPIRENONE;ESTETROLTABLET, CHEWABLE, TABLET, CAPSULE; ORAL3MG;14.2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-258Nextstellisdrospirenone and estetrolMayne PharmaNDACurrent
51862-258Nextstellisdrospirenone and estetrolMayne PharmaNDACurrent
51862-258Nextstellisdrospirenone and estetrolMayne PharmaNDACurrent
51862-258Nextstellisdrospirenone and estetrolMayne PharmaNDACurrent
51862-258Nextstellisdrospirenone and estetrolMayne PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70956SUPPL2022-05-03
70906SUPPL2022-05-02
67459ORIG2021-05-12
67081ORIG2021-04-16
67062ORIG2021-04-15