Drug application
CODEPREX (CHLORPHENIRAMINE POLISTIREX, CODEINE POLISTIREX)
Drugs@FDA NDA 021369 · LANNETT CO INC
Key facts
| Drug name | CODEPREX |
|---|---|
| Active ingredients | CHLORPHENIRAMINE POLISTIREX, CODEINE POLISTIREX |
| Application type | NDA |
| Application number | 021369 |
| Company | LANNETT CO INC |
| Dosage forms | SUSPENSION, EXTENDED RELEASE, ORAL |
| Strength | EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Jun 21, 2004 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes 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: