Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091632
Company: TRIS PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML SUSPENSION, EXTENDED RELEASE;ORAL Prescription AB 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
10/01/2010 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/091632Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/27/2017 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/27/2017 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL; EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML SUSPENSION, EXTENDED RELEASE;ORAL Prescription No AB 091632 TRIS PHARMA INC
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML SUSPENSION, EXTENDED RELEASE;ORAL Prescription No AB 091671 NEOS THERAP INC

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