FDA.reportPublic FDA data

Application 021098

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YASMINDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL-283MG;0.03MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
0555-9131OCELLAdrospirenone and ethinyl estradiolTEVA PHARMACEUTICALS USA, INC.NDA AUTHORIZED GENERICCurrent
50419-402Yasmindrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-402Yasmindrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-402Yasmindrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-402Yasmindrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-402Yasmindrospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
76413-130Yasmindrospirenone and ethinyl estradiolCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74344SUPPL 2023-05-22
74331SUPPL 2023-05-22
70932SUPPL2022-05-03
70888SUPPL2022-05-02
49372SUPPL2017-08-15
49296SUPPL2017-08-09
21449SUPPL2016-02-03
14385SUPPL2015-06-04
4331SUPPL2015-06-03
26764SUPPL2012-04-12
36114SUPPL2012-04-10
4330SUPPL2012-02-17
14384SUPPL2012-02-13
23625ORIG2011-11-16
36113SUPPL2010-04-19
4329SUPPL2010-04-09
4328SUPPL2003-05-30
14383SUPPL2003-05-13
36112ORIG2001-05-11
21448ORIG2001-05-11
4327ORIG2001-05-11