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Generated: November 21, 2018

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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 three suppliers. There are five 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. Three suppliers are 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:5
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 A-S Medication Solutions 50090-2835 50090-2835-0 1 BLISTER PACK in 1 CARTON (50090-2835-0) > 1 TABLET in 1 BLISTER PACK
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Aug 13, 2010TE:ABRLD:Yes
Patent:➤ Try a Free 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:➤ Try a Free TrialPatent Expiration:Jun 2, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Feb 20, 2029Product Flag?YSubstance Flag?Delist Request?

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