FDA.reportPublic FDA data

Application 204061

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUARTETTEETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6031RivelsaLevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51285-431QUARTETTELevonorgestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.NDACurrent
51862-489Levonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolMayne Pharma Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71745SUPPL2022-08-08
71744SUPPL2022-08-08
71727SUPPL2022-08-05
71726SUPPL2022-08-05
70949SUPPL2022-05-03
70898SUPPL2022-05-02
49382SUPPL2017-08-15
49333SUPPL2017-08-11
44893ORIG2013-04-25
22940ORIG2013-04-25
19519ORIG2013-04-01
32497ORIG2013-03-29
51305ORIG1900-01-01
51304ORIG1900-01-01
51303ORIG1900-01-01
51302ORIG1900-01-01