Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021983
Company: MMT
Company: MMT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DUODOTE | ATROPINE; PRALIDOXIME CHLORIDE | 2.1MG/0.7ML;600MG/2ML | INJECTABLE;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/17/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021983Orig1s038lbl.pdf | |
| 05/17/2022 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021983Orig1s038lbl.pdf | |
| 10/06/2017 | SUPPL-23 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021983s023lbl.pdf | |
| 10/06/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021983s023lbl.pdf |