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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Medtronic
Argus Health
Merck
Fish and Richardson
Moodys
QuintilesIMS
Deloitte
Mallinckrodt

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017919

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NDA 017919 describes ORTHO-NOVUM 1/35-28, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ORTHO-NOVUM 1/35-28 profile page.

The generic ingredient in ORTHO-NOVUM 1/35-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 017919
Tradename:ORTHO-NOVUM 1/35-28
Applicant:Janssen Pharms
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017919
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO-NOVUM 1/35-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 017919 NDA Janssen Pharmaceuticals, Inc. 50458-176 N 50458-176-06
ORTHO-NOVUM 1/35-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 017919 NDA Janssen Pharmaceuticals, Inc. 50458-176 N 50458-176-15

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Teva
McKesson
Cerilliant
Fish and Richardson
Julphar
Mallinckrodt
Boehringer Ingelheim
Covington

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