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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209115
Company: PHARMAAND

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2025	SUPPL-15	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209115Orig1s014,s015ltr.pdf
12/17/2025	SUPPL-14	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209115Orig1s014,s015ltr.pdf
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
12/17/2025	SUPPL-15	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf
12/17/2025	SUPPL-14	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf
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

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