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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215813
Company: AVYXA HOLDINGS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 160MG/16ML INJECTABLE;INJECTION Prescription None No No
DOCIVYX DOCETAXEL 20MG/2ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
DOCIVYX DOCETAXEL 80MG/8ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
DOCIVYX DOCETAXEL 160MG/16ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
11/22/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215813s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215813Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215813Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2024 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215813s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215813Orig1s001; s002ltr.pdf
04/11/2024 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215813s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215813Orig1s001; s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/11/2024 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215813s001s002lbl.pdf
04/11/2024 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215813s001s002lbl.pdf
04/11/2024 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215813s001s002lbl.pdf
11/22/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215813s000lbl.pdf
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