Details for New Drug Application (NDA): 016709

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NDA 016709 describes ORTHO-NOVUM 1/50 28, which is a drug marketed by Ortho Mcneil Janssen and is included in one NDA. Additional details are available on the ORTHO-NOVUM 1/50 28 profile page.

The generic ingredient in ORTHO-NOVUM 1/50 28 is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.

Summary for 016709

Tradename:	ORTHO-NOVUM 1/50 28
Applicant:	Ortho Mcneil Janssen
Ingredient:	mestranol; norethindrone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.05MG;1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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