Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022474
Company: LAB HRA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELLA ULIPRISTAL ACETATE 30MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/13/2010 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022474s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/10/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022474s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022474Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022474Orig1s007TOC.cfm
04/07/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/28/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s005lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s005ltr.pdf
06/12/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s004ltr.pdf
06/27/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/02/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022474s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022474s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/10/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022474s007lbl.pdf
08/28/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s005lbledt.pdf
06/12/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s004lbl.pdf
05/02/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022474s002lbl.pdf
08/13/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf

ELLA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELLA ULIPRISTAL ACETATE 30MG TABLET;ORAL Prescription Yes AB 022474 LAB HRA PHARMA
LOGILIA ULIPRISTAL ACETATE 30MG TABLET;ORAL Prescription No AB 207952 TEVA PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English