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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202594

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NDA 202594 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 202594

Tradename:	DROSPIRENONE AND ETHINYL ESTRADIOL
Applicant:	Xiromed
Ingredient:	drospirenone; ethinyl estradiol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG;0.02MG
Approval Date:	Oct 22, 2015	TE:	AB	RLD:	No

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