e-Drug3D

1501

cas 151533-22-1

CLASS

GENITO
PREMENSTRUAL DYSPHORIC DISORDER (PMDD)
ACNE
FOLATE SUPPLEMENTATION
RAISE FOLATE LEVELS FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY
SUPPLEMENT

ROUTE (list)

ORAL

PK parameters

t1/2 4.5 HOUR (0.451 MILLIGRAM)

MW 457.45
NB_atoms 33
XLogP -2.93
PSA 188.105
NB_HD 6
NB_HA 13
fsp3 0.35
Lipinski(0=no;1=yes) 0

FDA
NDA 022532 (label) INN (DROSPIRENONE ; ETHINYL ESTRADIOL ; LEVOMEFOLATE CALCIUM) BEYAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010
NDA 022574 (label) INN (DROSPIRENONE ; ETHINYL ESTRADIOL ; LEVOMEFOLATE CALCIUM) SAFYRAL (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010
NDA 203593 (label) INN (DROSPIRENONE ; ETHINYL ESTRADIOL ; LEVOMEFOLATE CALCIUM) DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016
NDA 203594 (label) INN (DROSPIRENONE ; ETHINYL ESTRADIOL ; LEVOMEFOLATE CALCIUM) DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016
NDA 205948 (pdf not found) INN (DROSPIRENONE ; ETHINYL ESTRADIOL ; LEVOMEFOLATE CALCIUM) TYDEMY (LUPIN LTD) APPROVAL= AP YEAR= 2017
NDA 205947 (pdf not found) INN (DROSPIRENONE ; ETHINYL ESTRADIOL ; LEVOMEFOLATE CALCIUM) DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (LUPIN LTD) APPROVAL= AP YEAR= 2018