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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 017489

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NDA 017489 describes ORTHO-NOVUM 1/35-21, which is a drug marketed by Ortho Mcneil Pharm and is included in one NDA. Additional details are available on the ORTHO-NOVUM 1/35-21 profile page.

The generic ingredient in ORTHO-NOVUM 1/35-21 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 017489

Tradename:	ORTHO-NOVUM 1/35-21
Applicant:	Ortho Mcneil Pharm
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.035MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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