Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 021780
Company: EVUS
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 |
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