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Generated: April 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204848

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NDA 204848 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: 204848

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

Suppliers and Packaging for NDA: 204848

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28 204848 ANDA A-S Medication Solutions 50090-2494 50090-2494-0 1 KIT in 1 KIT (50090-2494-0)
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28 204848 ANDA Glenmark Pharmaceuticals Inc., USA 68462-733 68462-733-29 3 BLISTER PACK in 1 CARTON (68462-733-29) > 1 KIT in 1 BLISTER PACK (68462-733-84)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:Mar 25, 2016TE:ABRLD:No


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