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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210063
Company: AVYXA HOLDINGS

Products on NDA 210063

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLIGAVYX	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210063

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210063Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2025	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210063s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210063Orig1s010ltr.pdf
11/12/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210063s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210063Orig1s003ltr.pdf
04/06/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210063s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210063Orig1s002ltr.pdf

Labels for NDA 210063

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2025	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210063s010lbl.pdf
11/21/2025	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210063s010lbl.pdf
11/12/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210063s003lbl.pdf
04/06/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210063s002lbl.pdf
08/19/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210063s000lbl.pdf

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