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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 205876

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NDA 205876 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 205876

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	3MG;0.03MG
Approval Date:	Sep 21, 2016	TE:		RLD:	No

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