Application 022501

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LO LOESTRIN FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	0.01MG,0.01MG;1MG,N/A	Yes	Yes
002	LO LOESTRIN FE	ETHINYL ESTRADIOL	TABLET; ORAL	10MCG	Yes	No
003	LO LOESTRIN FE	FERROUS FUMARATE	TABLET; ORAL	75MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0430-0420	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
50090-1456	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	A-S Medication Solutions	NDA	Current
50090-1456	Lo Loestrin Fe	norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70993	SUPPL	2022-05-04
70942	SUPPL	2022-05-03
69021	SUPPL	2021-10-19
69011	SUPPL	2021-10-18
50025	SUPPL	2017-10-12
50011	SUPPL	2017-10-11
49387	SUPPL	2017-08-15
49306	SUPPL	2017-08-10
44762	ORIG	2011-05-13
42540	ORIG	2011-05-13
29786	ORIG	2010-10-26
17648	ORIG	2010-10-25
54122	ORIG	1900-01-01
54121	ORIG	1900-01-01
54120	ORIG	1900-01-01