Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213150
Company: TOLMAR

• Medication Guide

Products on NDA 213150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENSOLVI KIT	LEUPROLIDE ACETATE	45MG	POWDER;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2020	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213150s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213150Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213150Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2022	SUPPL-3		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213150Orig1s003ltr.pdf
04/22/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213150Orig1s002ltr.pdf

Labels for NDA 213150

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2022	SUPPL-3	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s003lbl.pdf
04/22/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s002lbl.pdf
05/01/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213150s000lbl.pdf