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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210308
Company: SUN PHARM

Products on NDA 210308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YONSA	ABIRATERONE ACETATE	125MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210308

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210308s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210308Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210308Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2022	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210308Orig1s003ltr.pdf
01/28/2022	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210308Orig1s002ltr.pdf
09/17/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210308s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210308Orig1s001ltr.pdf

Labels for NDA 210308

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2022	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s003lbl.pdf
03/24/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s003lbl.pdf
01/28/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s002lbl.pdf
01/28/2022	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s002lbl.pdf
09/17/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210308s001lbl.pdf
05/22/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210308s000lbl.pdf

Therapeutic Equivalents for NDA 210308

YONSA

TABLET;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
YONSA	ABIRATERONE ACETATE	125MG	TABLET;ORAL	Prescription	Yes	AB	210308	SUN PHARM

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