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Drugs@FDA: FDA-Approved Drugs

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

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