FDA.reportPublic FDA data

Application 075256

Type
ANDA
Sponsor
DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-210.15MG;0.03MGNoNo
002DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG;0.03MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3304ReclipsenDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3304ReclipsenDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9043ApriDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9043ApriDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9043ApriDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9043ApriDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-2481ApriDesogestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2481ApriDesogestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
53002-1631ReclipsenDesogestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1631ReclipsenDesogestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39474SUPPL2004-06-02
39473SUPPL2004-06-02
39472SUPPL2004-06-02
39471SUPPL2004-06-02
39470SUPPL2004-06-02
30821SUPPL2004-06-02
30820SUPPL2004-06-02
30819SUPPL2004-06-02
30818SUPPL2004-06-02
18397SUPPL2004-06-02
18396SUPPL2004-06-02
18395ORIG2004-06-02
8587SUPPL2004-06-02
8586SUPPL2004-06-02
8585SUPPL2004-06-02
42967SUPPL2003-07-29
42966SUPPL2003-07-29
42965SUPPL2003-07-29
22448SUPPL2003-07-29
22447SUPPL2003-07-29
22446SUPPL2003-07-29
22445SUPPL2003-07-29
22444ORIG2003-07-29
8584ORIG1999-08-12