Details for New Drug Application (NDA): 021367

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NDA 021367 describes FEMRING, which is a drug marketed by Millicent and is included in one NDA. It is available from one supplier. Additional details are available on the FEMRING profile page.

The generic ingredient in FEMRING is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

Summary for 021367

Tradename:	FEMRING
Applicant:	Millicent
Ingredient:	estradiol acetate
Patents:	0

Pharmacology for NDA: 021367

Mechanism of Action	Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 021367

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367	NDA	Millicent US, Inc.	72495-201	72495-201-05	1 POUCH in 1 CARTON (72495-201-05) / 90 d in 1 POUCH
FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367	NDA	Millicent US, Inc.	72495-202	72495-202-10	1 POUCH in 1 CARTON (72495-202-10) / 90 d in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT, EXTENDED RELEASE;VAGINAL			Strength	EQ 0.05MG BASE/24HR
Approval Date:	Mar 20, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT, EXTENDED RELEASE;VAGINAL			Strength	EQ 0.1MG BASE/24HR
Approval Date:	Mar 20, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021367

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003	⤷ Sign Up	⤷ Sign Up
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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