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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/08/1982 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018658Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018658Orig1s034ltr.pdf | |
| 09/23/2019 | SUPPL-31 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018658Orig1s031ltr.pdf |
| 06/19/2014 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Proprietary Name Change |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018658Orig1s030ltr.pdf | |
| 05/16/2011 | SUPPL-29 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018658s029ltr.pdf |
| 11/10/2010 | SUPPL-28 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018658s028ltr.pdf |
| 04/08/2010 | SUPPL-27 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018658s027ltr.pdf |
| 10/08/2009 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018658s026ltr.pdf |
| 12/05/2008 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018658s023ltr.pdf |
| 09/28/2007 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018658s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018658s022ltr.pdf | |
| 03/08/2005 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18658s018ltr.pdf |
| 11/10/2004 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18658s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018658_S017_DELSYM_AP.pdf |
| 07/10/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2002 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18658S15LTR.PDF |
| 02/15/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/09/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/26/1993 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/10/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1986 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/12/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/10/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018658Orig1s034lbl.pdf | |
| 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 |
DELSYM
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION, EXTENDED RELEASE;ORAL; EQ 30MG HYDROBROMIDE/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DELSYM | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 018658 | RB HLTH |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE;ORAL | Over-the-counter | No | 203133 | AMNEAL |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE;ORAL | Over-the-counter | No | 091135 | TRIS PHARMA INC |