Drug application
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE)
Drugs@FDA ANDA 040027 · HIKMA PHARMS
Key facts
| Drug name | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 040027 |
| Company | HIKMA PHARMS |
| Dosage forms | SYRUP, ORAL |
| Strength | 15MG/5ML;6.25MG/5ML |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Jul 31, 1996 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No 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: