An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209115
Company: ZR PHARMA

Products on NDA 209115

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RUBRACA	RUCAPARIB CAMSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	None	Yes	No
RUBRACA	RUCAPARIB CAMSYLATE	EQ 300MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
RUBRACA	RUCAPARIB CAMSYLATE	EQ 250MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209115

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2016	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209115Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209115Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209115Orig1s013ltr.pdf
06/10/2022	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209115Orig1s011ltr.pdf
09/30/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209115s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209115Orig1s009ltr.pdf
10/08/2020	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209115Orig1s008ltr.pdf
05/15/2020	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209115Orig1s004ltr.pdf
04/06/2018	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209115Orig1s003ltr.pdf

Labels for NDA 209115

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s013lbl.pdf
06/10/2022	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s011lbl.pdf
09/30/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209115s009lbl.pdf
10/08/2020	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s008lbl.pdf
05/15/2020	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s004lbl.pdf
04/06/2018	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf
12/19/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf

Top