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Merck
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US Army
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078324

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NDA 078324 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, and Teva Pharms Usa, and is included in five NDAs. It is available from three suppliers. Additional details are available on the ESTRADIOL AND NORETHINDRONE ACETATE profile page.

The generic ingredient in ESTRADIOL AND NORETHINDRONE ACETATE is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 078324
Tradename:ESTRADIOL AND NORETHINDRONE ACETATE
Applicant:Breckenridge Pharm
Ingredient:estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078324
Suppliers and Packaging for NDA: 078324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324 ANDA Breckenridge Pharmaceutical, Inc. 51991-474 N 51991-474-28
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324 ANDA Breckenridge Pharmaceutical, Inc. 51991-623 N 51991-623-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Apr 17, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Jun 9, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Merck
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AstraZeneca
Dow
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Covington
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