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Application 076784

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI LO SPRINTECETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2140Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2140Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2140Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2140Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-2326Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2326Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
68788-7036Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7036Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolPreferred PharmaceuticalsANDACurrent
68788-7036Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7036Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7036Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals Inc.ANDACurrent
71205-287Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-287Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-287Tri-Lo-SprintecNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31165ORIG2009-07-08