Drug application
DIMETANE-DX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE)
Drugs@FDA NDA 019279 · ROBINS AH
Key facts
| Drug name | DIMETANE-DX |
|---|---|
| Active ingredients | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 019279 |
| Company | ROBINS AH |
| Dosage forms | SYRUP, ORAL |
| Strength | 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |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 3 - New Dosage Form |
| Latest submission status date | Aug 24, 1984 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
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: