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Details for New Drug Application (NDA): 021367

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NDA 021367 describes FEMRING, which is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug. 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. Three suppliers are listed for this compound. Additional details are available on the estradiol acetate profile page.

Summary for NDA: 021367

Tradename:
FEMRING
Applicant:
Apil
Ingredient:
estradiol acetate
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021367

Ingredient-typeEstradiol Congeners
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 Allergan, Inc. 0023-5868 0023-5868-05 1 POUCH in 1 CARTON (0023-5868-05) > 90 d in 1 POUCH
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL 021367 NDA Allergan, Inc. 0023-5869 0023-5869-10 1 POUCH in 1 CARTON (0023-5869-10) > 90 d in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT, EXTENDED RELEASE;VAGINALStrengthEQ 0.05MG BASE/24HR
Approval Date:Mar 20, 2003TE:RLD:No
Patent:5,855,906Patent Expiration:Dec 19, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER PATTERN FOR AT LEAST THREE WEEKS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INSERT, EXTENDED RELEASE;VAGINALStrengthEQ 0.1MG BASE/24HR
Approval Date:Mar 20, 2003TE:RLD:Yes
Patent:5,855,906Patent Expiration:Dec 19, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER PATTERN FOR AT LEAST THREE WEEKS

Expired Orange Book Patents for NDA: 021367

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-001Mar 20, 20035,855,906► subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-002Mar 20, 20035,855,906► subscribe
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