Application 022574

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	TABLET;ORAL	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
0781-4103	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Sandoz Inc	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-403	Safyral	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74342	SUPPL	2023-05-22
74330	SUPPL	2023-05-22
70945	SUPPL	2022-05-03
70900	SUPPL	2022-05-02
49384	SUPPL	2017-08-15
49297	SUPPL	2017-08-09
42563	SUPPL	2016-02-03
22062	SUPPL	2016-02-03
17730	SUPPL	2015-06-04
7559	SUPPL	2015-06-03
29875	SUPPL	2012-04-12
17729	SUPPL	2012-04-10
7558	SUPPL	2012-02-21
17728	SUPPL	2012-02-14
23714	ORIG	2011-11-16
44782	ORIG	2011-07-15
42562	ORIG	2011-07-15
38857	ORIG	2010-12-22
7557	ORIG	2010-12-21
53245	ORIG	1900-01-01
53244	ORIG	1900-01-01
53243	ORIG	1900-01-01

Application 022574

Related Records#

Application Products#

NDC Listings For This Application#

Documents#