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Last Updated: May 13, 2021

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Details for New Drug Application (NDA): 021633

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NDA 021633 describes FEMTRACE, which is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug. Additional details are available on the FEMTRACE profile page.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol acetate profile page.
Summary for 021633
Tradename:FEMTRACE
Applicant:Apil
Ingredient:estradiol acetate
Patents:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021633
Generic Entry Date for 021633*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.45MG
Approval Date:Aug 20, 2004TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Dec 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Get Started for $10Patent Expiration:Oct 2, 2025Product Flag?Substance Flag?Delist Request?
Patent:  Get Started for $10Patent Expiration:Dec 21, 2021Product Flag?YSubstance Flag?Delist Request?

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