Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206438
Company: TRIS PHARMA INC

Products on ANDA 206438

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.