Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021879
Company: OTSUKA AMERICA PHARM
Company: OTSUKA AMERICA PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUEDEXTA | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | 20MG;10MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/11/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021879s014lbl.pdf | |
| 01/31/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021879s012lbl.pdf | |
| 01/20/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021879s005lbl.pdf | |
| 10/29/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021879s000lbl.pdf |