Orange Book product
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Orange Book ANDA 091632 · TRIS PHARMA INC · Prescription
Key facts
| Proprietary name | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX |
|---|---|
| Active ingredients | CHLORPHENIRAMINE POLISTIREX, HYDROCODONE POLISTIREX |
| Strength | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML |
| Dosage form | SUSPENSION, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA091632 |
| Applicant holder | TRIS PHARMA INC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Oct 1, 2010 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.