FDA.reportPublic FDA data

Application 209405

Type
NDA
Sponsor
EXELTIS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET, CHEWABLE;ORAL0.02MG;0.1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0642-7471Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolExeltis USA, Inc.NDACurrent
0642-7471Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolExeltis USA, Inc.NDACurrent
0642-7471TyblumeLevonorgestrel and Ethinyl EstradiolExeltis USA, Inc.NDACurrent
0642-7471TyblumeLevonorgestrel and Ethinyl EstradiolExeltis USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70959SUPPL2022-05-04
70889SUPPL2022-05-02
64551ORIG2020-09-10
63386SUPPL2020-06-02
63382SUPPL2020-06-02
62465ORIG2020-04-07
62384ORIG2020-03-31