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Details for NDA: 021367

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Summary for NDA: 021367

Tradename:
FEMRING
Applicant:
Galen Ltd
Ingredient:
estradiol acetate
Patents:1
Suppliers: see list2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)

Pharmacology for NDA: 021367

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Glossary

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
Glossary

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


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