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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Deloitte
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200747

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NDA 200747 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Barr, Breckenridge Pharm, Mylan Labs Ltd, and Teva Pharms Usa, and is included in four 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 200747
Tradename:ESTRADIOL AND NORETHINDRONE ACETATE
Applicant:Teva Pharms Usa
Ingredient:estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200747
Suppliers and Packaging for NDA: 200747
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 200747 ANDA Teva Pharmaceuticals USA, Inc. 0093-5454 0093-5454-62 3 BLISTER PACK in 1 CARTON (0093-5454-62) > 28 TABLET in 1 BLISTER PACK
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 200747 ANDA Teva Pharmaceuticals USA, Inc. 0093-5454 0093-5454-28 1 BLISTER PACK in 1 CARTON (0093-5454-28) > 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Mar 8, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Covington
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Boehringer Ingelheim
Moodys
Daiichi Sankyo
McKinsey

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