FDA.reportPublic FDA data

Application 021676

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YAZDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL3MG;0.02MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-5423GianviDrospirenone and ethinyl estradiolTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
50419-405YazDrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-405YazDrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-405YazDrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-405YazDrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-405YazDrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-405YazDrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
66116-470GianviDrospirenone and ethinyl estradiolMedVantx, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74343SUPPL 2023-05-22
74328SUPPL 2023-05-22
70936SUPPL2022-05-03
70887SUPPL2022-05-02
67646SUPPL2021-06-01
49375SUPPL2017-08-15
49294SUPPL2017-08-09
42266SUPPL2016-02-03
15962SUPPL2015-06-04
28351SUPPL2015-06-03
5964SUPPL2012-04-12
37436SUPPL2012-04-10
44141ORIG2011-11-16
5962SUPPL2011-03-16
15960SUPPL2011-03-14
15961SUPPL2010-04-16
5963SUPPL2010-04-12
42265ORIG2007-08-06
5961SUPPL2007-02-02
28350ORIG2006-03-23
15959ORIG2006-03-22