Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021780
Company: EVUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROMIST NITROGLYCERIN 0.4MG/SPRAY AEROSOL, METERED;SUBLINGUAL 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
11/02/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021780s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021780_nitromist_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/10/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021780s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021780Orig1s007ltr.pdf
03/08/2011 SUPPL-3 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021780s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021780s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021780s007lbl.pdf
03/08/2011 SUPPL-3 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021780s003lbl.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