FDA.reportPublic FDA data

Application 075863

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KARIVADESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG,N/A;0.02MG,0.01MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9050KarivaDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9050KarivaDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9050KarivaDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9050KarivaDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9050KarivaDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9050KarivaDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
51285-120MircetteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-120MircetteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-120MircetteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51285-120MircetteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolTeva Women's Health, Inc.ANDACurrent
51862-072AzuretteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-072AzuretteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
53002-1600AzuretteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1600AzuretteDesogestrel/Ethinyl Estradiol and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31038ORIG2003-04-15
31039ORIG2003-04-10