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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202131

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NDA 202131 describes DROSPIRENONE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr, Cyndea Pharma, Glenmark Pharms Ltd, 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 nine 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. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 202131
Applicant:Mylan Labs Ltd
Ingredient:drospirenone; ethinyl estradiol
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 202131 ANDA Mylan Pharmaceuticals Inc. 0378-7300 N 0378-7300-53

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:May 4, 2015TE:ABRLD:No

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Harvard Business School
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