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Serving leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Fish and Richardson
Novartis
Julphar
UBS
Cantor Fitzgerald
Mallinckrodt
Daiichi Sankyo
Farmers Insurance

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020130

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NDA 020130 describes ESTROSTEP FE, which is a drug marketed by Apil and is included in one NDA. It is available from five suppliers. Additional details are available on the ESTROSTEP FE profile page.

The generic ingredient in ESTROSTEP FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 020130
Tradename:ESTROSTEP FE
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130 NDA Allergan, Inc. 0430-0005 N 0430-0005-31
ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130 NDA Warner Chilcott (US), LLC 0430-0570 E 0430-0570-60

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 9, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
Approval Date:Oct 9, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ➤ 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:

Argus Health
Accenture
Fish and Richardson
Covington
US Department of Justice
McKinsey
Cerilliant
US Army
Deloitte

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