Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216793
Company: JANSSEN BIOTECH

Products on NDA 216793

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	500MG;EQ 50MG BASE	TABLET;ORAL	Prescription	None	Yes	No
AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	500MG;EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216793

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2023	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216793s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216793Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216793Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2025	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216793Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216793Orig1s001ltr.pdf

Labels for NDA 216793

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2025	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf
08/11/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216793s000lbl.pdf