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Generated: May 24, 2017

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Details for New Drug Application (NDA): 204296

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NDA 204296 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: 204296

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204296

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
drospirenone; ethinyl estradiol
TABLET;ORAL 204296 ANDA A-S Medication Solutions 50090-2594 50090-2594-0 1 KIT in 1 KIT (50090-2594-0)
drospirenone; ethinyl estradiol
TABLET;ORAL 204296 ANDA Glenmark Pharmaceuticals Inc., USA 68462-720 68462-720-29 3 BLISTER PACK in 1 CARTON (68462-720-29) > 1 KIT in 1 BLISTER PACK (68462-720-84)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:Aug 17, 2015TE:ABRLD:No

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