Application 016131

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLOMIDCLOMIPHENE CITRATETABLET;ORAL50MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0677Clomiphene CitrateClomiphene CitrateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82806SUPPL 2025-07-11
50908SUPPL2017-12-27
50760SUPPL2017-12-19
40711SUPPL2016-02-02
421SUPPL2012-10-24
33146SUPPL2012-10-22