FdaApplication
ANDA 091632
Identifiers
- fda_app_no: ANDA091632
Properties
| Property | Value |
|---|---|
| applicant_name | TRIS PHARMA INC |
| application_type | ANDA |
| approval_date | 2010-10-01 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX | CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML | SUSPENSION, EXTENDED RELEASE;ORAL |
1 product