FDA.reportPublic FDA data

Application 021544

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEASONALEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.03MG;0.15MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9123JolessaLevonorgestrel / Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0555-9123JolessaLevonorgestrel / Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0555-9123JolessaLevonorgestrel / Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0555-9123JolessaLevonorgestrel / Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0555-9123JolessaLevonorgestrel / Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
53002-1779JolessaLevonorgestrel / Ethinyl EstradiolRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73337SUPPL2023-01-30
73336SUPPL2023-01-30
73321SUPPL2023-01-30
73320SUPPL2023-01-30
70895SUPPL2022-05-02
49376SUPPL2017-08-15
49330SUPPL2017-08-10
47843SUPPL2017-04-03
47842SUPPL2017-04-03
47815SUPPL2017-04-03
47814SUPPL2017-04-03
21727ORIG2004-03-24
28078ORIG2003-09-25
15737ORIG2003-09-25