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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021864

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NDA 021864 describes LYBREL, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the LYBREL profile page.

The generic ingredient in LYBREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 021864

Tradename:	LYBREL
Applicant:	Wyeth Pharms Inc
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.02MG;0.09MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 22, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 021864

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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