ulipristal acetate

FDA Drug Profile — Ella

ulipristal acetate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Ella. Available dosage form: tablet.

Drug Details

Generic Name
ulipristal acetate
Brand Names
Ella
Application Number
NDA022474
Sponsor
PMI Branded Pharmaceuticals, Inc.
NDC Codes
3
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ULIPRISTAL ACETATE

Indications and Usage

1 INDICATIONS AND USAGE Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . E lla is not intended for routine use as a contraceptive. Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella is not intended for routine use as a contraceptive. ( 1 )