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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Julphar
Colorcon
Chubb
Daiichi Sankyo
Baxter
Express Scripts
Cipla
Argus Health

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079218

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NDA 079218 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms Ltd, Lupin Ltd, Mayne Pharma, Mylan Labs Ltd, Watson Labs, Barr, and Labs Leon Farma, and is included in twenty-five NDAs. It is available from eight suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 079218
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:Watson Labs
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079218
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Physiological EffectInhibit Ovum Fertilization
Suppliers and Packaging for NDA: 079218
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 079218 ANDA Actavis Pharma, Inc. 52544-295 N 52544-295-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;0.09MG
Approval Date:Jun 6, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Accenture
Argus Health
Merck
Federal Trade Commission
Julphar
Healthtrust
US Army

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