Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018658
Company: RB HLTH
Company: RB HLTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DELSYM | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/19/2014 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf | |
| 06/19/2014 | SUPPL-30 | Labeling-Proprietary Name Change | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf | |
| 09/28/2007 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018658s022lbl.pdf | |
| 09/28/2007 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018658s022lbl.pdf |