FDA.reportPublic FDA data

Application 076455

Type
ANDA
Sponsor
DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VELIVETDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MGNoNo
002DESOGESTREL; ETHINYLDESOGESTREL; ETHINYL ESTRADIOLTablet; Oral0.125MG/0.025MGNoNo
003DESOGESTREL; ETHINYLDESOGESTREL; ETHINYL ESTRADIOLTablet; Oral0.15MG/0.025MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9051VelivetDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9051VelivetDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9051VelivetDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9051VelivetDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9051VelivetDesogestrel and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
51862-238CaziantDesogestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-238CaziantDesogestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
53002-1628CaziantDesogestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1628CaziantDesogestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1775VelivetDesogestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
70518-0059CaziantDesogestrel and Ethinyl EstradiolREMEDYREPACK INC.ANDACurrent