Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022196
Company: AYTU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLPIMIST ZOLPIDEM TARTRATE 5MG/SPRAY SPRAY, METERED;ORAL 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
12/19/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022196S000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2019 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022196Orig1s011ltr.pdf
09/28/2011 SUPPL-7 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022196s007ltr.pdf
10/11/2010 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022196s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2019 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s011lbl.pdf
12/19/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English