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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 022474


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NDA 022474 describes ELLA, which is a drug marketed by Lab Hra Pharma and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ELLA profile page.

The generic ingredient in ELLA is ulipristal acetate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ulipristal acetate profile page.
Summary for 022474
Tradename:ELLA
Applicant:Lab Hra Pharma
Ingredient:ulipristal acetate
Patents:7
Pharmacology for NDA: 022474
Suppliers and Packaging for NDA: 022474
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELLA ulipristal acetate TABLET;ORAL 022474 NDA Afaxys Pharma LLC 50102-911 50102-911-01 1 BLISTER PACK in 1 CARTON (50102-911-01) > 1 TABLET in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022474
Tradename Dosage Ingredient NDA Submissiondate
ELLA TABLET;ORAL ulipristal acetate 022474 2014-08-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Aug 13, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 13, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR CONTRACEPTION COMPRISING THE STEP OF ORAL ADMINISTRATION A DOSAGE OF 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE
Patent:  Start TrialPatent Expiration:Jun 12, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:ELLA IS A PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
Patent:  Start TrialPatent Expiration:Jun 2, 2030Product Flag?YSubstance Flag?Delist Request?

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