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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Cantor Fitzgerald
Express Scripts

Generated: July 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203339

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NDA 203339 describes AMABELZ, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the AMABELZ profile page.

The generic ingredient in AMABELZ 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 203339
Applicant:Lupin Ltd
Ingredient:estradiol; norethindrone acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 203339
Suppliers and Packaging for NDA: 203339
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMABELZ estradiol; norethindrone acetate TABLET;ORAL 203339 ANDA Lupin Pharmaceuticals, Inc. 68180-829 N 68180-829-13
AMABELZ estradiol; norethindrone acetate TABLET;ORAL 203339 ANDA Lupin Pharmaceuticals, Inc. 68180-830 N 68180-830-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Jun 20, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Jun 20, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
US Department of Justice
Federal Trade Commission
Queensland Health

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