FDA.reportPublic FDA data

Application 075804

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPRINTECETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9016SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA,ANDACurrent
0555-9016SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9016SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9016SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-769SprintecNorgestimate and Ethinyl EstradiolRebel Distributors CorpANDACurrent
63187-911SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
63187-911SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
63187-911SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
63187-911SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
63629-8746SprintecNorgestimate and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-8746SprintecNorgestimate and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-8746SprintecNorgestimate and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-8746SprintecNorgestimate and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
63629-8746SprintecNorgestimate and Ethinyl EstradiolBryant Ranch PrepackANDACurrent
68788-7429SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7429SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7429SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7429SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7429SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43026ORIG2007-07-06