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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 017612

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NDA 017612 describes LO/OVRAL, which is a drug marketed by Cadence Health and Wyeth Pharms and is included in two NDAs. Additional details are available on the LO/OVRAL profile page.

The generic ingredient in LO/OVRAL is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for 017612

Tradename:	LO/OVRAL
Applicant:	Cadence Health
Ingredient:	ethinyl estradiol; norgestrel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.03MG;0.3MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017612

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982	3,666,858	⤷ Get Started Free
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982	3,959,322	⤷ Get Started Free
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982	3,850,911	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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