Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020845
Company: MALLINCKRODT HOSP
Company: MALLINCKRODT HOSP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INOMAX | NITRIC OXIDE | 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GAS;INHALATION | Discontinued | None | Yes | No |
| INOMAX | NITRIC OXIDE | 800PPM | GAS;INHALATION | Prescription | AA | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/13/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020845s020lbl.pdf | |
| 10/09/2015 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf | |
| 10/09/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf | |
| 03/04/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020845s014lbl.pdf | |
| 12/21/2010 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020845s011lbl.pdf | |
| 08/26/2009 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020845s009lbl.pdf | |
| 12/23/1999 | ORIG-1 | Approval | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20845lbl.htm |
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