FDA.reportPublic FDA data

Application 021355

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANGELIQDROSPIRENONE; ESTRADIOLTABLET;ORAL0.25MG;0.5MGYesNo
002ANGELIQDROSPIRENONE; ESTRADIOLTABLET;ORAL0.5MG;1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-482Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-482Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-482Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-482Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-482Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-482Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-483Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-483Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-483Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-483Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-483Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-483Angeliqdrospirenone and estradiolBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77529SUPPL 2024-02-16
77518SUPPL 2024-02-16
75671SUPPL 2023-10-03
75670SUPPL 2023-10-03
75668SUPPL 2023-10-03
75667SUPPL 2023-10-03
59315SUPPL2019-07-11
50262SUPPL2017-11-02
27567SUPPL2015-07-09
15262SUPPL2015-07-01
5134SUPPL2012-03-02
5133SUPPL2012-03-02
15261SUPPL2012-03-01
15260SUPPL2012-03-01
42117ORIG2007-09-11
27566ORIG2005-10-20
36734ORIG2005-09-30