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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018985

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NDA 018985 describes ORTHO-NOVUM 7/7/7-28, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ORTHO-NOVUM 7/7/7-28 profile page.

The generic ingredient in ORTHO-NOVUM 7/7/7-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for 018985

Tradename:	ORTHO-NOVUM 7/7/7-28
Applicant:	Janssen Pharms
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:	Apr 4, 1984	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 4, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 018985

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,616,006	⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,530,839	⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,628,051	⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,544,554	⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,628,051	⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,530,839	⤷ Get Started Free
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,616,006	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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