Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203838
Company: TRIS PHARMA INC

Products on ANDA 203838

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203838

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2014	ORIG-1	Approval				Label is not available on this site.