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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Queensland Health
Federal Trade Commission

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075256

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NDA 075256 describes DESOGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Duramed Pharms Barr, Accord Hlthcare, Aurobindo Pharma Ltd, Mayne Pharma, Mylan Labs Ltd, Novast Labs Ltd, and Watson Labs, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the DESOGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in DESOGESTREL AND ETHINYL ESTRADIOL is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 075256
Applicant:Duramed Pharms Barr
Ingredient:desogestrel; ethinyl estradiol
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075256
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-21 075256 ANDA Teva Pharmaceuticals USA, Inc. 0093-3304 N 0093-3304-16
DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-21 075256 ANDA Teva Pharmaceuticals USA, Inc. 0555-9043 N 0555-9043-58

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.15MG;0.03MG
Approval Date:Aug 12, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Aug 12, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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