Details for New Drug Application (NDA): 022501

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NDA 022501 describes LO LOESTRIN FE, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the LO LOESTRIN FE profile page.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 022501

Tradename:	LO LOESTRIN FE
Applicant:	Apil
Ingredient:	ethinyl estradiol; norethindrone acetate
Patents:	1

Suppliers and Packaging for NDA: 022501

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501	NDA	Allergan, Inc.	0430-0420	0430-0420-14	5 BLISTER PACK in 1 CARTON (0430-0420-14) / 1 KIT in 1 BLISTER PACK
LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501	NDA	Allergan, Inc.	0430-0420	0430-0420-60	8 CARTON in 1 TRAY (0430-0420-60) / 30 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.01MG,0.01MG;1MG,N/A
Approval Date:	Oct 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 2, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION

Expired US Patents for NDA 022501

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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