Application 020683

Type
NDA
Sponsor
CADENCE HEALTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALESSEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-210.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ALESSEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79134SUPPL 2024-07-22
79106SUPPL 2024-07-17
70977SUPPL2022-05-04
70929SUPPL2022-05-03
53491SUPPL2018-03-28
53253SUPPL2018-03-23
49427SUPPL2017-08-16
49307SUPPL2017-08-10
35128SUPPL2008-02-14
13190SUPPL2008-02-14
13189SUPPL2008-02-14
3067SUPPL2008-02-05
3066SUPPL2008-02-05
3065SUPPL2008-02-05
20817ORIG2003-08-08