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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 218031

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NDA 218031 describes DROSPIRENONE AND ESTRADIOL, which is a drug marketed by Novast Labs and is included in one NDA. Additional details are available on the DROSPIRENONE AND ESTRADIOL profile page.

The generic ingredient in DROSPIRENONE AND ESTRADIOL is drospirenone; estradiol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estradiol profile page.

Summary for 218031

Tradename:	DROSPIRENONE AND ESTRADIOL
Applicant:	Novast Labs
Ingredient:	drospirenone; estradiol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG;1MG
Approval Date:	Oct 28, 2025	TE:	AB	RLD:	No

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