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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020301

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NDA 020301 describes ORTHO-CEPT, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ORTHO-CEPT profile page.

The generic ingredient in ORTHO-CEPT is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for 020301

Tradename:	ORTHO-CEPT
Applicant:	Janssen Pharms
Ingredient:	desogestrel; ethinyl estradiol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.15MG;0.03MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 1992	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.15MG;0.03MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 1992	TE:		RLD:	Yes

Expired US Patents for NDA 020301

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-21	020301-001	Dec 14, 1992	3,927,046	⤷ Get Started Free
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020301-002	Dec 14, 1992	3,927,046	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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