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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Argus Health
Healthtrust
Harvard Business School
Boehringer Ingelheim
Daiichi Sankyo
McKinsey
Farmers Insurance

Generated: August 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075840

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NDA 075840 describes CRYSELLE, which is a drug marketed by Duramed Pharms Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the CRYSELLE profile page.

The generic ingredient in CRYSELLE is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075840
Tradename:CRYSELLE
Applicant:Duramed Pharms Barr
Ingredient:ethinyl estradiol; norgestrel
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075840
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRYSELLE ethinyl estradiol; norgestrel TABLET;ORAL-21 075840 ANDA Teva Pharmaceuticals USA, Inc. 0555-9049 N 0555-9049-58
CRYSELLE ethinyl estradiol; norgestrel TABLET;ORAL-21 075840 ANDA REMEDYREPACK INC. 70518-1214 N 70518-1214-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.03MG;0.3MG
Approval Date:Nov 30, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.3MG
Approval Date:Nov 30, 2001TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chubb
Healthtrust
Fish and Richardson
Cerilliant
US Department of Justice
Cipla
US Army
Moodys

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