Details for New Drug Application (NDA): 204654

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NDA 204654 describes LO MINASTRIN FE, which is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug. Additional details are available on the LO MINASTRIN FE profile page.

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

Summary for 204654

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE, TABLET;ORAL			Strength	0.01MG,0.01MG,N/A;1MG,N/A,N/A
Approval Date:	Jul 24, 2013	TE:		RLD:	Yes
Patent:	7,704,984	Patent Expiration:	Feb 2, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY

Expired US Patents for NDA 204654

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	5,552,394	⤷ Start Trial
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	6,667,050	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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