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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022474
Company: LAB HRA PHARMA

Summary Review

Products on NDA 022474

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELLA	ULIPRISTAL ACETATE	30MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022474

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
06/24/2021	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022474s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022474Orig1s011ltr.pdf
05/01/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022474s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022474Orig1s010ltr.pdf
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

Labels for NDA 022474

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2021	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022474s011lbl.pdf
05/01/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022474s010lbl.pdf
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

Therapeutic Equivalents for NDA 022474

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

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