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New Drug Application (NDA): 210308
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YONSA ABIRATERONE ACETATE 125MG TABLET;ORAL Prescription AB Yes Yes
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
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

YONSA

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABIRATERONE ACETATE ABIRATERONE ACETATE 125MG TABLET;ORAL Prescription No AB 212206 TEVA PHARMS USA
YONSA ABIRATERONE ACETATE 125MG TABLET;ORAL Prescription Yes AB 210308 SUN PHARM
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