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Generated: May 22, 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 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 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 N 0093-5454-28
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 200747 ANDA Teva Pharmaceuticals USA, Inc. 0093-5454 N 0093-5454-62

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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