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Generated: May 29, 2017

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, Mylan Labs Ltd, Watson Labs, Accord Hlthcare, Glenmark Pharms Ltd, Lupin Ltd, Apotex Inc, and Mayne Pharma, and is included in eleven 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. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for NDA: 202131

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0378-7300-53 3 POUCH in 1 CARTON (0378-7300-53) > 1 KIT in 1 POUCH

Summary 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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