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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090081

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NDA 090081 describes DROSPIRENONE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr, Glenmark Pharms Ltd, Mylan Labs Ltd, PII, Watson Labs, Accord Hlthcare, Apotex Inc, Lupin Ltd, and Mayne Pharma, and is included in twelve 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 090081

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 090081 ANDA Mayne Pharma Inc. 51862-036 51862-036-03 3 BLISTER PACK in 1 CARTON (51862-036-03) > 1 KIT in 1 BLISTER PACK (51862-036-01)
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 090081 ANDA Watson Pharma, Inc. 52544-981 52544-981-31 3 BLISTER PACK in 1 CARTON (52544-981-31) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:Sep 7, 2010TE:ABRLD:No


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