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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 020130

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NDA 020130 describes ESTROSTEP FE, which is a drug marketed by Apil and is included in one NDA. Additional details are available on the ESTROSTEP FE profile page.

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

Summary for 020130

Tradename:	ESTROSTEP FE
Applicant:	Apil
Ingredient:	ethinyl estradiol; norethindrone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 9, 1996	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 9, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020130

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	⤷ Get Started Free	⤷ Get Started Free
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	⤷ Get Started Free	⤷ Get Started Free
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	⤷ Get Started Free	⤷ Get Started Free
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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