Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021134
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROSTAT | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | No |
| NITROSTAT | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | No |
| NITROSTAT | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/24/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021134s010lbl.pdf | |
| 01/31/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021134s009lbl.pdf | |
| 08/29/2016 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021134s008lbl.pdf | |
| 03/07/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021134s007lbl.pdf | |
| 07/21/2011 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf | |
| 07/12/2010 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdf | |
| 05/01/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21134lbl.pdf |