Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019886
Company: PFIZER

• Medication Guide

Products on NDA 19886

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYNAREL	NAFARELIN ACETATE	EQ 0.2MG BASE/SPRAY	SPRAY, METERED;NASAL	Prescription	None	Yes	Yes

Labels for NDA 019886

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2023	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019886s039lbl.pdf
04/22/2022	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019886s038lbl.pdf
05/19/2017	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf
05/19/2017	SUPPL-35	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf
05/19/2017	SUPPL-35	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf
05/19/2017	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf
08/08/2015	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf
01/11/2012	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf
01/04/2011	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
01/04/2011	SUPPL-27	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
01/04/2011	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
01/04/2011	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
04/12/2006	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019886s022lbl.pdf