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Last Updated: March 28, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021367
Mechanism of ActionEstrogen 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:RXDosage:INSERT, EXTENDED RELEASE;VAGINALStrengthEQ 0.05MG BASE/24HR
Approval Date:Mar 20, 2003TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INSERT, EXTENDED RELEASE;VAGINALStrengthEQ 0.1MG BASE/24HR
Approval Date:Mar 20, 2003TE:RLD:Yes

Expired US Patents for NDA 021367

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

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