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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Chinese Patent Office
Express Scripts
Harvard Business School
Fish and Richardson
Daiichi Sankyo

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076238

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NDA 076238 describes BALZIVA-28, which is a drug marketed by Barr and is included in one NDA. It is available from one supplier. Additional details are available on the BALZIVA-28 profile page.

The generic ingredient in BALZIVA-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 076238
Ingredient:ethinyl estradiol; norethindrone
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076238
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALZIVA-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 076238 ANDA Teva Pharmaceuticals USA, Inc. 0093-3305 N 0093-3305-16
BALZIVA-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 076238 ANDA Teva Pharmaceuticals USA, Inc. 0555-9034 N 0555-9034-58

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Apr 22, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo

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