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Generated: May 22, 2018

DrugPatentWatch Database Preview

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. It is available from three suppliers. 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. Eighteen 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
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018985
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985 NDA Janssen Pharmaceuticals, Inc. 50458-178 N 50458-178-06
ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985 NDA Janssen Pharmaceuticals, Inc. 50458-178 N 50458-178-12

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:Apr 4, 1984TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:Apr 4, 1984TE:ABRLD:Yes

Expired US Patents for NDA 018985

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 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985-001 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985-001 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018985-002 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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