Drug application
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE)
Drugs@FDA NDA 011265 · ANI PHARMS
Key facts
| Drug name | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 011265 |
| Company | ANI PHARMS |
| Dosage forms | SYRUP, ORAL |
| Strength | 15MG/5ML;6.25MG/5ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Dec 3, 1957 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- 1–9 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: