FDA.reportPublic FDA data

Application 022252

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATAZIADIENOGEST; ESTRADIOL VALERATETABLET;ORALN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-4110Estradiol Valerate and Estradiol Valerate/Dienogestestradiol valerate and estradiol valerate/dienogestSandoz IncNDA AUTHORIZED GENERICCurrent
0781-4110Estradiol Valerate and Estradiol Valerate/Dienogestestradiol valerate and estradiol valerate/dienogestSandoz IncNDA AUTHORIZED GENERICCurrent
0781-4110Estradiol Valerate and Estradiol Valerate/Dienogestestradiol valerate and estradiol valerate/dienogestSandoz IncNDA AUTHORIZED GENERICCurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-409Nataziaestradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78917SUPPL 2024-06-27
78906SUPPL 2024-06-27
70940SUPPL2022-05-03
70912SUPPL2022-05-03
38431SUPPL2015-08-25
7099SUPPL2015-08-24
29456SUPPL2013-08-23
17135SUPPL2013-08-22
38430ORIG2012-03-16
7098ORIG2012-03-16
29455SUPPL2012-02-15
17134SUPPL2012-02-14
24265ORIG2010-06-06
21970ORIG2010-06-06
17133ORIG2010-05-17
7097ORIG2010-05-12
63519ORIG1900-01-01
53269ORIG1900-01-01
53268ORIG1900-01-01