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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cerilliant
Baxter
US Army
Colorcon
Medtronic
Fish and Richardson
Cipla
Citi

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202594

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NDA 202594 describes DROSPIRENONE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr, Glenmark Pharms Ltd, Jubilant Cadista, Mylan Labs Ltd, PII, Watson Labs, Accord Hlthcare, Apotex Inc, Lupin Ltd, and Mayne Pharma, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the DROSPIRENONE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL is drospirenone; ethinyl estradiol. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 202594
Tradename:DROSPIRENONE AND ETHINYL ESTRADIOL
Applicant:Mylan Labs Ltd
Ingredient:drospirenone; ethinyl estradiol
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 202594 ANDA Mylan Pharmaceuticals Inc. 0378-7299 N 0378-7299-53

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:Oct 22, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
US Army
Daiichi Sankyo
McKinsey
Fish and Richardson
Chubb
Accenture
Deloitte

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