Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091135
Company: TRIS PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROMETHORPHAN POLISTIREX DEXTROMETHORPHAN POLISTIREX EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/2012 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091135Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/091135Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/28/2012 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

DEXTROMETHORPHAN POLISTIREX

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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