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Last Updated: December 15, 2025

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, Glenmark Pharms Ltd, Hetero Labs, Jubilant Cadista, Pharmobedient, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Lupin Ltd, and Naari Pte, and is included in sixteen 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 eleven 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 204296
Tradename:DROSPIRENONE AND ETHINYL ESTRADIOL
Applicant:Glenmark Pharms Ltd
Ingredient:drospirenone; ethinyl estradiol
Patents:0
Suppliers and Packaging for NDA: 204296
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL 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 AND ETHINYL ESTRADIOL 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)

Profile for product number 001

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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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