Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091632
Company: TRIS PHARMA INC
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 | Yes |
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 |