Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018658
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
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
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 PHARMS LLC
DEXTROMETHORPHAN POLISTIREX DEXTROMETHORPHAN POLISTIREX EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE;ORAL Over-the-counter No 091135 TRIS PHARMA INC

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