Drug application
TUSSIONEX PENNKINETIC (CHLORPHENIRAMINE POLISTIREX, HYDROCODONE POLISTIREX)
Drugs@FDA NDA 019111 · UCB INC
Key facts
| Drug name | TUSSIONEX PENNKINETIC |
|---|---|
| Active ingredients | CHLORPHENIRAMINE POLISTIREX, HYDROCODONE POLISTIREX |
| Application type | NDA |
| Application number | 019111 |
| Company | UCB INC |
| Dosage forms | SUSPENSION, EXTENDED RELEASE, ORAL |
| Strength | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Dec 31, 1987 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- No FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: