Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021633

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NDA 021633 describes FEMTRACE, which is a drug marketed by Apil and is included in one NDA. Additional details are available on the FEMTRACE profile page.

The generic ingredient in FEMTRACE is estradiol acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

Summary for 021633

Tradename:	FEMTRACE
Applicant:	Apil
Ingredient:	estradiol acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.45MG
Approval Date:	Aug 20, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.9MG
Approval Date:	Aug 20, 2004	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.8MG
Approval Date:	Aug 20, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021633

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004	6,962,908	⤷ Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	7,572,779	⤷ Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	7,799,771	⤷ Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	6,962,908	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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