Control Center right away at 1-800-222-1222. Overdose experience with ella is limited.
This Patient Information Leaflet summarizes the most important information about ella. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ella that is written for health professionals.
For more information, go to www.ella-rx.com or you can contact Watson Medical Communications at 1-800-272-5525.
What are the ingredients in ella?
Active ingredients: ulipristal acetate, 30 mg
Inactive ingredients: lactose monohydrate, povidone, croscarmellose sodium, and magnesium stearate
Address medical inquiries to:
WATSON
Medical Communications
P.O. Box 1953
Morristown, NJ 07962-1953
800-272-5525
Distributed By:
Watson Pharma, Inc.
Morristown, NJ 07962 USA
Under License From:
Laboratoire HRA Pharma
75003 Paris, France
ella® is a registered trademark
of Laboratoire HRA Pharma
Manufactured By:
Osny Pharma, 95520 Osny, France; or
León Farma S.A., 24008 León, Spain
PRINCIPAL DISPLAY PANEL
ella® (ulipristal acetate) tablet 30 mg
NDC 52544-238-54
Carton x 1 tablet
ELLA
ulipristal acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-238
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULIPRISTAL ACETATE (ULIPRISTAL) ULIPRISTAL ACETATE 30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
POVIDONE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code ella
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 52544-238-54 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (52544-238-54)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022474 08/13/2010
Labeler - Watson Pharma, Inc. (023932721)
Revised: 08/2010Watson Pharma, Inc.
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