Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019886
Company: GD SEARLE LLC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/1990 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019886Orig1s033s035ltr.pdf
05/19/2017 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019886Orig1s033s035ltr.pdf
08/08/2015 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019886Orig1s032ltr.pdf
03/25/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/11/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019886s030ltr.pdf
01/04/2011 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019886s026,s027ltr.pdf
01/04/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019886s026,s027ltr.pdf
04/12/2006 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019886s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019886s022ltr.pdf
06/28/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2001 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/06/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/29/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/06/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/24/1998 SUPPL-13 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19886s13ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019886S013%20.cfm
12/07/1995 SUPPL-12 Labeling

Label is not available on this site.

09/29/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/26/1994 SUPPL-10 Labeling

Label is not available on this site.

08/28/1991 SUPPL-6 Labeling

Label is not available on this site.

08/01/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-4 Labeling

Label is not available on this site.

03/25/1991 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1991 SUPPL-2 Labeling

Label is not available on this site.

03/16/1990 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-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-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-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

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