Application 022532

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BEYAZ	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	TABLET;ORAL	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-4075	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
50419-407	Beyaz	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-407	Beyaz	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-407	Beyaz	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-407	Beyaz	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-407	Beyaz	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74345	SUPPL	2023-05-22
74329	SUPPL	2023-05-22
70971	SUPPL	2022-05-04
70943	SUPPL	2022-05-03
49386	SUPPL	2017-08-15
49295	SUPPL	2017-08-09
42553	SUPPL	2016-02-03
22048	SUPPL	2016-02-03
17688	SUPPL	2015-06-04
29839	SUPPL	2015-06-03
29838	SUPPL	2012-04-12
17687	SUPPL	2012-04-10
7510	SUPPL	2012-02-21
17686	SUPPL	2012-02-14
23712	ORIG	2011-11-16
44772	ORIG	2011-04-04
22047	ORIG	2011-04-04
38821	ORIG	2010-09-29
7509	ORIG	2010-09-29
53241	ORIG	1900-01-01
53240	ORIG	1900-01-01
53239	ORIG	1900-01-01
53238	ORIG	1900-01-01

Application 022532

Related Records#

Application Products#

NDC Listings For This Application#

Documents#