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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091135
Company: TRIS PHARMA INC

Products on ANDA 091135

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091135

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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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
DEXTROMETHORPHAN POLISTIREX	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE;ORAL	Over-the-counter	No	218417	AUROBINDO PHARMA LTD
DEXTROMETHORPHAN POLISTIREX	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE;ORAL	Over-the-counter	No	091135	TRIS PHARMA INC

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