Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019886
Company: PFIZER
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 01/31/2023 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019886s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019886Orig1s039ltr.pdf | |
| 04/22/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019886s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019886Orig1s038ltr.pdf | |
| 05/19/2017 | SUPPL-35 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
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-Package Insert, Labeling-Patient Package Insert, 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 |
|---|---|---|---|---|---|
| 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-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-35 | Labeling-Package Insert | 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-Package Insert | 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 | 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 |